NDC 10967-679 Eight Hour Lip Spf 15

Petrolatum, Padimate O, Oxybenzone

NDC Product Code 10967-679

NDC 10967-679-61

Package Description: 3.7 g in 1 CARTRIDGE

NDC Product Information

Eight Hour Lip Spf 15 with NDC 10967-679 is a a human over the counter drug product labeled by Revlon. The generic name of Eight Hour Lip Spf 15 is petrolatum, padimate o, oxybenzone. The product's dosage form is lipstick and is administered via topical form.

Labeler Name: Revlon

Dosage Form: Lipstick - A waxy solid, usually colored cosmetic, in stick form for the lips.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Eight Hour Lip Spf 15 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OXYBENZONE 3 mg/g
  • PETROLATUM 30.2 mg/g
  • PADIMATE O 8 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • CORN OIL (UNII: 8470G57WFM)
  • CITRAL (UNII: T7EU0O9VPP)
  • GERANIOL (UNII: L837108USY)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • CETYL LACTATE (UNII: A7EVH2RK4O)
  • LANOLIN OIL (UNII: OVV5IIJ58F)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • CERESIN (UNII: Q1LS2UJO3A)
  • MYRISTYL LACTATE (UNII: 1D822OC34X)
  • CETYL ACETATE (UNII: 4Q43814HXS)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • MYRISTYL ALCOHOL (UNII: V42034O9PU)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)
  • GLYCERYL ROSINATE (UNII: SD112V492J)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Revlon
Labeler Code: 10967
FDA Application Number: part352 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 10-21-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Eight Hour Lip Spf 15 Product Label Images

Eight Hour Lip Spf 15 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Active Ingredients Purpose

PETROLATUM 30.2% ............. Skin Protectant

PADIMATE O 8.0%....................Sunscreen

OXYBENZONE 3.0%.................Sunscreen

Inactive Ingredients

RICINUS COMMUNIS (CASTOR) SEED OIL, OZOKERITE, GLYCERYL ROSINATE, CETYL LACTATE, LANOLIN OIL, MYRISTYL LACTATE, CETYL ACETATE, EUPHORBIA CERIFERA (CANDELILLA) WAX/CANDELILLA CERA/CIRE DE CANDELILLA, COPERNICIA CERIFERA (CARNAUBA) WAX/CERA CARNAUBA/CIRE DE CARNAUBA, MYRISTYL ALCOHOL, ACETYLATED LANOLIN ALCOHOL, BEESWAX/CERA ALBA/CIRE D'ABEILLE, CAPRYLYL GLYCOL, GLYCINE SOJA (SOYBEAN) OIL, METHYLSTYRENE/VINYLTOLUENE COPOLYMER, MICROCRYSTALLINE WAX/CERA MICROCRISTALLINA/CIRE MICROCRISTALLINE, PARFUM/FRAGRANCE, TOCOPHEROL, ZEA MAYS (CORN) OIL, BHT, CITRAL, CITRONELLOL, GERANIOL, LIMONENE, LINALOOL, PHENOXYETHANOL, IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

Uses

  • Useshelps prevent sunburnTemporarily protects and helps relieve - chapping - peeling or flaking due to minor sunburn - windburn - cracked lips

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 prevent sunburn, not skin cancer or early skin aging.
  • For external use onlyDo not use on damaged or broken skinStop use and ask a doctor if rash occurs or if condition lasts more than 7 days.Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions For Use

  • DirectionsApply liberally as often as necessaryFor Sunscreen Use:Apply liberally 15 minutes before sun exposurereapply: - at least every 2 hourschildren under 6 months: Ask a doctor.

* Please review the disclaimer below.