Label: CERAMIDE PREMIERE BROAD SPECTRUM SPF 30- octinoxate, octisalate, oxybenzone, octocrylene, avobenzone emulsion
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Contains inactivated NDC Code(s)
NDC Code(s): 10967-669-17 - Packager: REVLON
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 9, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients Purpose
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Inactive Ingredients
WATER/AQUA/EAU, DIMETHICONE, GLYCERIN, HYDROGENATED POLYISOBUTENE, PETROLATUM, GLYCERYL STEARATE, BUTYLENE GLYCOL, BUTYLOCTYL SALICYLATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARYL ALCOHOL, PEG-100 STEARATE, BUTYROSPERMUM PARKII (SHEA BUTTER), HYDROGENATED LECITHIN, DIMETHYL CAPRAMIDE, CERAMIDE 1, CERAMIDE 3, CERAMIDE 6 II, FUCUS SERRATUS EXTRACT, YEAST EXTRACT/FAEX/EXTRAIT DE LEVURE, RETINYL LINOLEATE, TOCOPHERYL ACETATE, CETEARYL DIMETHICONE CROSSPOLYMER, PEG-40 HYDROGENATED CASTOR OIL, SOY AMINO ACIDS, 3-AMINOPROPANE SULFONIC ACID, CALCIUM HYDROXYMETHIONINE, HYDROLYZED SOY PROTEIN, METHYL METHACRYLATE CROSSPOLYMER, PHYTOSPHINGOSINE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, CHOLESTEROL, SODIUM LAUROYL LACTYLATE, PEG-8 LAURATE, POLYSORBATE 20, SODIUM DODECYLBENZENESULFONATE, STYRENE/ACRYLATES COPOLYMER, BEHENYL ALCOHOL, PENTYLENE GLYCOL, CARBOMER, HYDROXYETHYLCELLULOSE, POLYETHYLENE, XANTHAN GUM, EDTA, SODIUM HYDROXIDE, BHT, DISODIUM EDTA, MICA, TIN OXIDE, AMINOPROPYL DIMETHICONE, FRAGRANCE/PARFUM, ALPHA-ISOMETHYL IONONE, BUTYLPHENYL METHYLPROPIONAL, CITRONELLOL, HYDROXYCITRONELLAL, ETHYLPARABEN, METHYLPARABEN, PHENOXYETHANOL, POTASSIUM SORBATE, PROPYLPARABEN, SODIUM BENZOATE, TITANIUM DIOXIDE (CI 77891).
- Uses
- Warnings
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Directions For Sunscreen Use
- Apply liberally 15 minutes before sun exposure
- Reapply:
- at least every 2 hours- 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 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-sleeve shirts, pants, hats, and sunglasses- Children under 6 months: Ask a doctor.
- Artwork
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INGREDIENTS AND APPEARANCE
CERAMIDE PREMIERE BROAD SPECTRUM SPF 30
octinoxate, octisalate, oxybenzone, octocrylene, avobenzone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-669 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 3 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mg in 1 g Inactive Ingredients Ingredient Name Strength HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6) CHOLESTEROL (UNII: 97C5T2UQ7J) GLYCERIN (UNII: PDC6A3C0OX) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) ETHYLPARABEN (UNII: 14255EXE39) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYSORBATE 20 (UNII: 7T1F30V5YH) STANNIC OXIDE (UNII: KM7N50LOS6) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) XANTHAN GUM (UNII: TTV12P4NEE) CERAMIDE 1 (UNII: 5THT33P7X7) FUCUS SERRATUS (UNII: V8K40WNW5B) EDETATE DISODIUM (UNII: 7FLD91C86K) AMINO ACIDS, SOY (UNII: NWB9514AZM) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) DIMETHICONE (UNII: 92RU3N3Y1O) EDETIC ACID (UNII: 9G34HU7RV0) MICA (UNII: V8A1AW0880) WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ) CERAMIDE 6 II (UNII: F1X8L2B00J) PEG-100 STEARATE (UNII: YD01N1999R) SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y) SODIUM HYDROXIDE (UNII: 55X04QC32I) PEG-8 LAURATE (UNII: 762O8IWA10) TRAMIPROSATE (UNII: 5K8EAX0G53) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) AMINOPROPYL DIMETHICONE (1000 MPA.S) (UNII: P4P48I53XH) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLPARABEN (UNII: A2I8C7HI9T) DOCOSANOL (UNII: 9G1OE216XY) PHENOXYETHANOL (UNII: HIE492ZZ3T) DESMENINOL CALCIUM (UNII: 1VK0YS654L) SODIUM BENZOATE (UNII: OJ245FE5EU) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) PETROLATUM (UNII: 4T6H12BN9U) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) CERAMIDE 3 (UNII: 4370DF050B) YEAST (UNII: 3NY3SM6B8U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10967-669-17 49 g in 1 JAR; Type 0: Not a Combination Product 02/06/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/06/2017 Labeler - REVLON (788820165) Registrant - REVLON (788820165) Establishment Name Address ID/FEI Business Operations Englewood Lab. INC. 080987545 manufacture(10967-669)
