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

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    AVOBENZONE 3.00%

    HOMOSALATE 10.0%

    OCTISALATE 5.0%

    OCTOCRYLENE 8.0%

  • 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

    • Helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • 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 and ask a doctor if rash occurs
    • keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • 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

    15 mL Tube

  • INGREDIENTS AND APPEARANCE
    ADVANCED CERAMIDE LIFT AND FIRM DAY CREAM  BROAD SPECTRUM SUNSCREEN SPF 15
    octisalate, octocrylene, avobenzone, homosalate emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10967-689
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10967-689-6115 g in 1 TUBE; Type 0: Not a Combination Product08/01/2021
    2NDC:10967-689-645 g in 1 TUBE; Type 0: Not a Combination Product08/01/2021
    3NDC:10967-689-1750 g in 1 JAR; Type 0: Not a Combination Product08/01/2021
    4NDC:10967-689-602 g in 1 PACKET; Type 0: Not a Combination Product08/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/2021
    Labeler - REVLON (788820165)
    Registrant - REVLON (788820165)
    Establishment
    NameAddressID/FEIBusiness Operations
    REVLON, INC.809725570manufacture(10967-689)