Positive Light Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen 52w
Homosalate, Titanium Dioxide, Zinc Oxide
Rare Beauty, Llc
Human Otc Drug
NDC 82109-120Positive Light Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen 52w also known as Homosalate, Titanium Dioxide, Zinc Oxide is a human otc drug labeled by 'Rare Beauty, Llc'. National Drug Code (NDC) number for Positive Light Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen 52w is 82109-120. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Positive Light Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen 52w drug includes Homosalate - 90 mg/mL Titanium Dioxide - 18 mg/mL Zinc Oxide - 9 mg/mL . The currest status of Positive Light Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen 52w drug is Active.
Drug Information:
| Drug NDC: | 82109-120 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Positive Light Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen 52w |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Homosalate, Titanium Dioxide, Zinc Oxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Rare Beauty, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | HOMOSALATE - 90 mg/mL
TITANIUM DIOXIDE - 18 mg/mL
ZINC OXIDE - 9 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 30 Mar, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part352 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Rare Beauty, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 15FIX9V2JP
V06SV4M95S
SOI2LOH54Z
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 82109-120-01 | 1 BOTTLE, PLASTIC in 1 CARTON (82109-120-01) / 30 mL in 1 BOTTLE, PLASTIC | 30 Mar, 2022 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose sunscreen
Product Elements:
Positive light tinted moisturizer broad spectrum spf 20 sunscreen 54n homosalate, titanium dioxide, zinc oxide cetyl peg/ppg-10/1 dimethicone (hlb 5) lecithin, soybean triethoxycaprylylsilane alkyl (c12-15) benzoate .alpha.-tocopherol acetate dimethicone/vinyl dimethicone crosspolymer (soft particle) magnesium sulfate, unspecified sodium dehydroacetate sunflower oil nelumbo nucifera flower ferric oxide red dimethicone disteardimonium hectorite aluminum hydroxide aluminum oxide propylene carbonate sorbitol titanium dioxide titanium dioxide isopentyldiol phenoxyethanol sodium chloride hydrogen dimethicone (20 cst) potassium sorbate benzoic acid homosalate homosalate zinc oxide zinc oxide water dehydroacetic acid tocopherol ethylhexylglycerin ascorbyl palmitate citric acid monohydrate gardenia jasminoides fruit nymphaea odorata root ferric oxide yellow ferrosoferric oxide talc isododecane positive light tinted moisturizer broad spectrum spf 20 sunscreen 56n homosalate, titanium dioxide, zinc oxide cetyl peg/ppg-10/1 dimethicone (hlb 5) lecithin, soybean triethoxycaprylylsilane alkyl (c12-15) benzoate .alpha.-tocopherol acetate dimethicone/vinyl dimethicone crosspolymer (soft particle) magnesium sulfate, unspecified sodium dehydroacetate sunflower oil nelumbo nucifera flower ferric oxide red dimethicone disteardimonium hectorite aluminum hydroxide aluminum oxide propylene carbonate sorbitol titanium dioxide titanium dioxide isopentyldiol phenoxyethanol sodium chloride hydrogen dimethicone (20 cst) potassium sorbate benzoic acid homosalate homosalate zinc oxide zinc oxide water dehydroacetic acid tocopherol ethylhexylglycerin ascorbyl palmitate citric acid monohydrate gardenia jasminoides fruit nymphaea odorata root ferric oxide yellow ferrosoferric oxide talc isododecane positive light tinted moisturizer broad spectrum spf 20 sunscreen 58n homosalate, titanium dioxide, zinc oxide cetyl peg/ppg-10/1 dimethicone (hlb 5) lecithin, soybean triethoxycaprylylsilane alkyl (c12-15) benzoate .alpha.-tocopherol acetate dimethicone/vinyl dimethicone crosspolymer (soft particle) magnesium sulfate, unspecified sodium dehydroacetate sunflower oil nelumbo nucifera flower ferric oxide red dimethicone disteardimonium hectorite aluminum hydroxide aluminum oxide propylene carbonate sorbitol titanium dioxide titanium dioxide isopentyldiol phenoxyethanol sodium chloride hydrogen dimethicone (20 cst) potassium sorbate benzoic acid homosalate homosalate zinc oxide zinc oxide water dehydroacetic acid tocopherol ethylhexylglycerin ascorbyl palmitate citric acid monohydrate gardenia jasminoides fruit nymphaea odorata root ferric oxide yellow ferrosoferric oxide talc isododecane positive light tinted moisturizer broad spectrum spf 20 sunscreen 44n homosalate, titanium dioxide, zinc oxide sorbitol titanium dioxide titanium dioxide isopentyldiol phenoxyethanol sodium chloride hydrogen dimethicone (20 cst) potassium sorbate benzoic acid homosalate homosalate zinc oxide zinc oxide water dehydroacetic acid tocopherol ethylhexylglycerin ascorbyl palmitate citric acid monohydrate gardenia jasminoides fruit nymphaea odorata root ferric oxide yellow ferrosoferric oxide talc isododecane cetyl peg/ppg-10/1 dimethicone (hlb 5) lecithin, soybean triethoxycaprylylsilane alkyl (c12-15) benzoate .alpha.-tocopherol acetate dimethicone/vinyl dimethicone crosspolymer (soft particle) magnesium sulfate, unspecified sodium dehydroacetate sunflower oil nelumbo nucifera flower ferric oxide red dimethicone disteardimonium hectorite aluminum hydroxide aluminum oxide propylene carbonate positive light tinted moisturizer broad spectrum spf 20 sunscreen 46c homosalate, titanium dioxide, zinc oxide cetyl peg/ppg-10/1 dimethicone (hlb 5) lecithin, soybean triethoxycaprylylsilane alkyl (c12-15) benzoate .alpha.-tocopherol acetate dimethicone/vinyl dimethicone crosspolymer (soft particle) magnesium sulfate, unspecified sodium dehydroacetate sunflower oil nelumbo nucifera flower ferric oxide red dimethicone disteardimonium hectorite aluminum hydroxide aluminum oxide propylene carbonate sorbitol titanium dioxide titanium dioxide isopentyldiol phenoxyethanol sodium chloride hydrogen dimethicone (20 cst) potassium sorbate benzoic acid homosalate homosalate zinc oxide zinc oxide water dehydroacetic acid tocopherol ethylhexylglycerin ascorbyl palmitate citric acid monohydrate gardenia jasminoides fruit nymphaea odorata root ferric oxide yellow ferrosoferric oxide talc isododecane positive light tinted moisturizer broad spectrum spf 20 sunscreen 48w homosalate, titanium dioxide, zinc oxide sodium dehydroacetate sunflower oil nelumbo nucifera flower ferric oxide red dimethicone disteardimonium hectorite aluminum hydroxide aluminum oxide propylene carbonate sorbitol titanium dioxide titanium dioxide isopentyldiol phenoxyethanol sodium chloride hydrogen dimethicone (20 cst) potassium sorbate benzoic acid homosalate homosalate zinc oxide zinc oxide water dehydroacetic acid tocopherol ethylhexylglycerin ascorbyl palmitate citric acid monohydrate gardenia jasminoides fruit nymphaea odorata root ferric oxide yellow ferrosoferric oxide talc isododecane cetyl peg/ppg-10/1 dimethicone (hlb 5) lecithin, soybean triethoxycaprylylsilane alkyl (c12-15) benzoate .alpha.-tocopherol acetate dimethicone/vinyl dimethicone crosspolymer (soft particle) magnesium sulfate, unspecified positive light tinted moisturizer broad spectrum spf 20 sunscreen 50n homosalate, titanium dioxide, zinc oxide cetyl peg/ppg-10/1 dimethicone (hlb 5) lecithin, soybean triethoxycaprylylsilane alkyl (c12-15) benzoate .alpha.-tocopherol acetate dimethicone/vinyl dimethicone crosspolymer (soft particle) magnesium sulfate, unspecified sodium dehydroacetate sunflower oil nelumbo nucifera flower ferric oxide red dimethicone disteardimonium hectorite aluminum hydroxide aluminum oxide propylene carbonate sorbitol titanium dioxide titanium dioxide isopentyldiol phenoxyethanol sodium chloride hydrogen dimethicone (20 cst) potassium sorbate benzoic acid homosalate homosalate zinc oxide zinc oxide water dehydroacetic acid tocopherol ethylhexylglycerin ascorbyl palmitate citric acid monohydrate gardenia jasminoides fruit nymphaea odorata root ferric oxide yellow ferrosoferric oxide talc isododecane positive light tinted moisturizer broad spectrum spf 20 sunscreen 52w homosalate, titanium dioxide, zinc oxide cetyl peg/ppg-10/1 dimethicone (hlb 5) lecithin, soybean triethoxycaprylylsilane alkyl (c12-15) benzoate .alpha.-tocopherol acetate dimethicone/vinyl dimethicone crosspolymer (soft particle) magnesium sulfate, unspecified sodium dehydroacetate sunflower oil nelumbo nucifera flower ferric oxide red dimethicone disteardimonium hectorite aluminum hydroxide aluminum oxide propylene carbonate sorbitol titanium dioxide titanium dioxide isopentyldiol phenoxyethanol sodium chloride hydrogen dimethicone (20 cst) potassium sorbate benzoic acid homosalate homosalate zinc oxide zinc oxide water dehydroacetic acid tocopherol ethylhexylglycerin ascorbyl palmitate citric acid monohydrate gardenia jasminoides fruit nymphaea odorata root ferric oxide yellow ferrosoferric oxide talc isododecane
Indications and Usage:
Uses helps prevent sunburn
Warnings:
Warnings for external use only. do not use on damaged or broken skin. when using this product keep out of eyes. rinse with water to remove. stop use if irritation occurs and ask a doctor if a rash occurs. keep out of reach of children. if swallowed, get medical help right away.
Do Not Use:
Warnings for external use only. do not use on damaged or broken skin. when using this product keep out of eyes. rinse with water to remove. stop use if irritation occurs and ask a doctor if a rash occurs. keep out of reach of children. if swallowed, get medical help right away.
When Using:
When using this product keep out of eyes. rinse with water to remove.
Dosage and Administration:
Directions apply liberally and evenly 15 minutes before sun exposure. children under 6 months of age: ask a doctor. sun protection measures . spending time in the sun increases your risk of skin cancer and early skin aging. to decrease this risk, regularly use a sunscreen with a broad spectrum spf value of 15 or higher and other sun protection measures including limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses
Stop Use:
Stop use if irritation occurs and ask a doctor if a rash occurs.
Package Label Principal Display Panel:
44n 1 44n
46c 46c 1
48w 48w 1
50n 50n 1
52w 52w 1
54n 54n 1
56n 56n 1
58n 58n 1
Further Questions:
Questions? call 1-888-892-7273 monday-friday, 7am-4pm pst