Label: ADVANCED CERAMIDE LIFT AND FIRM DAY CREAM BROAD SPECTRUM SUNSCREEN SPF 15- octisalate, octocrylene, avobenzone, homosalate emulsion
- NDC Code(s): 10967-689-17, 10967-689-60, 10967-689-61, 10967-689-64
- 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 November 12, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
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OTHER INGREDIENTS
WATER/AQUA/EAU, GLYCERIN, HEXYLENE GLYCOL, DIMETHICONE, C14-22 ALCOHOLS, PEG-100 STEARATE, GLYCERYL STEARATE, STYRENE/ACRYLATES COPOLYMER, ACRYLATES/DIMETHICONE COPOLYMER, POLYMETHYLSILSESQUIXANE, ACETYL TETRAPEPTIDE-11, ACETYL TETRAPEPTIDE-9, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, AMMONIUM HYDROXIDE, BUTYLENE GLYCOL, C12-20 ALKYL GLUCOSIDE, CAPRYLYL GLYCOL, CARBOMER, CERAMIDE AP, CERAMIDE EOP, CERAMIDE NP, CHOLESTEROL, DIMETHYL ISOSORBIDE, DISODIUM EDTA, ETHLYHEXYL PALMITATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL, TAURATE COPOLYMER, ISOHEXADECANE, LEONTOPODIUM ALPINUM CALLUS CULTURE EXTRACT, MARIS SAL/SEA SALT/SEL MARIN, PHYTOSPHINGOSINE, POLYSORBATE 20, POLYSORBATE 60, SILICA DIMETHYL SILYLATE, SODIUM CARRAGEENAN, SODIUM HYALURONATE, SODIUM LAUROYL LACTYLATE, TOCOPHERYL ACETATE, TROMETHAMINE, XANTHAM GUM, FRAGRANCE, CHLORPHENESIN, PHENOXYETHANOL.
- USES
- WARNINGS
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DIRECTIONS
- 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
- Use a water resistant sunscreen if swimming or sweating
- Children under 6 months: Ask a doctor.
- CARTON ART
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INGREDIENTS AND APPEARANCE
ADVANCED CERAMIDE LIFT AND FIRM DAY CREAM BROAD SPECTRUM SUNSCREEN SPF 15
octisalate, octocrylene, avobenzone, homosalate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-689 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 80 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength HYALURONATE SODIUM (UNII: YSE9PPT4TH) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ACETYL TETRAPEPTIDE-9 (UNII: VMO8OOD3V0) LEONTOPODIUM NIVALE SUBSP. ALPINUM WHOLE (UNII: 99S85B4VEB) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) HEXYLENE GLYCOL (UNII: KEH0A3F75J) ACETYL TETRAPEPTIDE-11 (UNII: 0R3VC3BV8I) ETHYLHEXYL PALMITATE (UNII: 2865993309) CERAMIDE NP (UNII: 4370DF050B) TROMETHAMINE (UNII: 023C2WHX2V) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHOLESTEROL (UNII: 97C5T2UQ7J) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PEG-100 STEARATE (UNII: YD01N1999R) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) XANTHAN GUM (UNII: TTV12P4NEE) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) CHLORPHENESIN (UNII: I670DAL4SZ) POLYSORBATE 60 (UNII: CAL22UVI4M) POLYSORBATE 20 (UNII: 7T1F30V5YH) CERAMIDE AP (UNII: F1X8L2B00J) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) 2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) C14-22 ALCOHOLS (UNII: B1K89384RJ) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) ISOHEXADECANE (UNII: 918X1OUF1E) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) CERAMIDE 1 (UNII: 5THT33P7X7) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CARRAGEENAN SODIUM (UNII: 7CY8BVL34N) SEA SALT (UNII: 87GE52P74G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10967-689-61 15 g in 1 TUBE; Type 0: Not a Combination Product 08/01/2021 2 NDC:10967-689-64 5 g in 1 TUBE; Type 0: Not a Combination Product 08/01/2021 3 NDC:10967-689-17 50 g in 1 JAR; Type 0: Not a Combination Product 08/01/2021 4 NDC:10967-689-60 2 g in 1 PACKET; Type 0: Not a Combination Product 08/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/01/2021 Labeler - REVLON (788820165) Registrant - REVLON (788820165) Establishment Name Address ID/FEI Business Operations REVLON, INC. 809725570 manufacture(10967-689)