Neutrogena Revitalizing Lip Balm Spf 20 - Healthy Blush 20
Octinoxate And Oxybenzone
Johnson & Johnson Consumer Inc.
Human Otc Drug
NDC 69968-0253Neutrogena Revitalizing Lip Balm Spf 20 - Healthy Blush 20 also known as Octinoxate And Oxybenzone is a human otc drug labeled by 'Johnson & Johnson Consumer Inc.'. National Drug Code (NDC) number for Neutrogena Revitalizing Lip Balm Spf 20 - Healthy Blush 20 is 69968-0253. This drug is available in dosage form of Lipstick. The names of the active, medicinal ingredients in Neutrogena Revitalizing Lip Balm Spf 20 - Healthy Blush 20 drug includes Octinoxate - 75 mg/g Oxybenzone - 50 mg/g . The currest status of Neutrogena Revitalizing Lip Balm Spf 20 - Healthy Blush 20 drug is Active.
Drug Information:
| Drug NDC: | 69968-0253 |
| 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: | Neutrogena Revitalizing Lip Balm Spf 20 - Healthy Blush 20 |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Neutrogena Revitalizing Lip Balm |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | SPF 20 - Healthy Blush 20 |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Octinoxate And Oxybenzone |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Johnson & Johnson Consumer Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lipstick |
| 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: | OCTINOXATE - 75 mg/g
OXYBENZONE - 50 mg/g
|
| 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: | 01 Nov, 2010 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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, 2024 |
| 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: | Johnson & Johnson Consumer Inc.
|
| 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. |
| UPC: | 0086800009658
0086800009634
|
| UPC stands for Universal Product Code. |
| UNII: | 4Y5P7MUD51
95OOS7VE0Y
|
| 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 |
|---|
| 69968-0253-1 | 1 TUBE in 1 BLISTER PACK (69968-0253-1) / 4.2 g in 1 TUBE | 01 Nov, 2010 | 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:
Neutrogena revitalizing lip balm spf 20 - fresh plum 60 octinoxate and oxybenzone hydrogenated polybutene (1300 mw) petrolatum polybutene (1400 mw) phenyl trimethicone lanolin alcohols ceresin myristyl myristate high density polyethylene cetyl lactate shea butter candelilla wax silicon dioxide zinc carnauba wax ethylhexyl palmitate tribehenin sorbitan isostearate palmitoyl tripeptide-1 pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) isopropyl titanium triisostearate aluminum hydroxide stearic acid copper mica titanium dioxide ferric oxide red d&c red no. 7 octinoxate octinoxate oxybenzone oxybenzone neutrogena revitalizing lip balm spf 20 - sheeer shimmer 10 octinoxate and oxybenzone hydrogenated polybutene (1300 mw) petrolatum polybutene (1400 mw) phenyl trimethicone lanolin alcohols ceresin myristyl myristate high density polyethylene cetyl lactate shea butter candelilla wax silicon dioxide zinc carnauba wax ethylhexyl palmitate tribehenin sorbitan isostearate palmitoyl tripeptide-1 pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) isopropyl titanium triisostearate aluminum hydroxide stearic acid copper mica titanium dioxide ferric oxide red d&c red no. 7 octinoxate octinoxate oxybenzone oxybenzone neutrogena revitalizing lip balm spf 20 - soft caramel 50 octinoxate and oxybenzone hydrogenated polybutene (1300 mw) petrolatum polybutene (1400 mw) phenyl trimethicone lanolin alcohols ceresin myristyl myristate high density polyethylene cetyl lactate shea butter candelilla wax silicon dioxide zinc carnauba wax ethylhexyl palmitate tribehenin sorbitan isostearate palmitoyl tripeptide-1 pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) isopropyl titanium triisostearate aluminum hydroxide stearic acid copper mica titanium dioxide ferric oxide red octinoxate octinoxate oxybenzone oxybenzone neutrogena revitalizing lip balm spf 20 - healthy blush 20 octinoxate and oxybenzone hydrogenated polybutene (1300 mw) petrolatum polybutene (1400 mw) phenyl trimethicone lanolin alcohols ceresin myristyl myristate high density polyethylene cetyl lactate shea butter candelilla wax silicon dioxide zinc carnauba wax ethylhexyl palmitate tribehenin sorbitan isostearate palmitoyl tripeptide-1 pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) isopropyl titanium triisostearate aluminum hydroxide stearic acid copper mica titanium dioxide fd&c yellow no. 5 aluminum oxide d&c red no. 6 d&c red no. 7 stannic oxide octinoxate octinoxate oxybenzone oxybenzone neutrogena revitalizing lip balm spf 20 - sunny berry 30 octinoxate and oxybenzone hydrogenated polybutene (1300 mw) petrolatum polybutene (1400 mw) phenyl trimethicone lanolin alcohols ceresin myristyl myristate high density polyethylene cetyl lactate shea butter candelilla wax silicon dioxide zinc carnauba wax ethylhexyl palmitate tribehenin sorbitan isostearate palmitoyl tripeptide-1 pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) aluminum hydroxide stearic acid isopropyl titanium triisostearate copper mica titanium dioxide ferric oxide red d&c red no. 7 octinoxate octinoxate oxybenzone oxybenzone neutrogena revitalizing lip balm spf 20 - petal glow 40 octinoxate and oxybenzone hydrogenated polybutene (1300 mw) petrolatum polybutene (1400 mw) phenyl trimethicone lanolin alcohols ceresin myristyl myristate high density polyethylene cetyl lactate shea butter candelilla wax silicon dioxide zinc carnauba wax ethylhexyl palmitate tribehenin sorbitan isostearate palmitoyl tripeptide-1 pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) isopropyl titanium triisostearate aluminum hydroxide stearic acid copper mica titanium dioxide ferric oxide red fd&c yellow no. 5 aluminum oxide d&c red no. 7 octinoxate octinoxate oxybenzone oxybenzone
Indications and Usage:
Uses helps prevent sunburn
Warnings:
Warnings skin cancer/skin aging alert: spending time in the sun increases your risk of skin cancer and early skin aging. this product has been shown only to help prevent sunburn, not skin cancer or early skin aging. 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 and ask a doctor if rash occurs keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Do Not Use:
Warnings skin cancer/skin aging alert: spending time in the sun increases your risk of skin cancer and early skin aging. this product has been shown only to help prevent sunburn, not skin cancer or early skin aging. 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 and ask a doctor if rash occurs keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product keep out of eyes. rinse with water to remove.
Dosage and Administration:
Directions for sunscreen use apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months of age: ask a doctor
Stop Use:
Stop use and ask a doctor if rash occurs
Package Label Principal Display Panel:
Principal display panel - 4.2 g tube blister pack - fresh plum 60 fresh plum 60 sheer tint revitalizing lip balm with sunscreen spf 20 softer, rosier and healthier-looking lips, even after you take it off! dramatization before after neutrogena® net wt 0.15 oz (4.2 g) principal display panel - 4.2 g tube blister pack - fresh plum 60
Principal display panel - 4.2 g tube blister pack - sheer shimmer 10 sheer shimmer 10 sheer tint revitalizing lip balm with sunscreen spf 20 softer, rosier and healthier-looking lips, even after you take it off! dramatization before after neutrogena® net wt 0.15 oz (4.2 g) principal display panel - 4.2 g tube blister pack - sheer shimmer 10
Principal display panel - 4.2 g tube blister pack - soft caramel 50 soft caramel 50 sheer tint revitalizing lip balm with sunscreen spf 20 softer, rosier and healthier-looking lips, even after you take it off! dramatization before after neutrogena® net wt 0.15 oz (4.2 g) principal display panel - 4.2 g tube blister pack - soft caramel 50
Principal display panel - 4.2 g tube blister pack - healthy blush 20 healthy blush 20 sheer tint revitalizing lip balm with sunscreen spf 20 softer, rosier and healthier-looking lips, even after you take it off! dramatization before after neutrogena® net wt 0.15 oz (4.2 g) principal display panel - 4.2 g tube blister pack - healthy blush 20
Principal display panel - 4.2 g tube blister pack - sunny berry 30 sunny berry 30 sheer tint revitalizing lip balm with sunscreen spf 20 softer, rosier and healthier-looking lips, even after you take it off! dramatization before after neutrogena® net wt 0.15 oz (4.2 g) principal display panel - 4.2 g tube blister pack - sunny berry 30
Principal display panel - 4.2 g tube blister pack - petal glow 40 petal glow 40 sheer tint revitalizing lip balm with sunscreen spf 20 softer, rosier and healthier-looking lips, even after you take it off! dramatization before after neutrogena® net wt 0.15 oz (4.2 g) principal display panel - 4.2 g tube blister pack - petal glow 40
Further Questions:
Questions or comments? call toll-free 800-480-4812 or 215-273-8755 (collect) or visit www.neutrogena.com