Label: CERAMIDE MAKEUP SPF 15- octinoxate, titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 12, 2024

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

  • Active Ingredients Purpose

    OCTINOXATE 4.0%.............. Sunscreen
    TITANIUM DIOXIDE 3.0% .... Sunscreen

  • Inactive Ingredients

    Inactive Ingredients
    WATER/AQUA/EAU, CYCLOPENTASILOXANE, DIMETHICONE, ISOHEXADECANE, MICA, GLYCERIN, SORBITAN ISOSTEARATE, DIMETHICONE CROSSPOLYMER, ALUMINA, CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDE, ALUMINUM/MAGNESIUM HYDROXIDE STEARATE, ACETYL OCTAPEPTIDE-3, ALANINE, ALPINIA SPECIOSA LEAF EXTRACT, ASCORBYL PALMITATE, ASPARTIC ACID, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, CARBOMER, CERAMIDE 1, CERAMIDE 3, CERAMIDE 6 II, CHOLESTEROL, DEXTRIN, DISODIUM EDTA, FRUCTOSE, GLUCOSE, HEXYLENE GLYCOL, HIBISCUS ABELMOSCHUS SEED EXTRACT, LECITHIN, MANNITOL, PCA DIMETHICONE, PHYTOSPHINGOSINE, POLYPERFLUOROETHOXYMETHOXY DIFLUOROETHYL PEG PHOSPHATE, POLYQUATERNIUM-51, RETINYL PALMITATE, SILICA SILYLATE, SODIUM CHLORIDE, SODIUM HYALURONATE, SODIUM LAUROYL LACTYLATE, SODIUM PCA, SORBITOL, SUCROSE, TOCOPHEROL, TREHALOSE, TRIFOLIUM PRATENSE (CLOVER) FLOWER EXTRACT, UREA, XANTHAN GUM, ZINC STEARATE, BHT, BENZOIC ACID, CHLORPHENESIN, METHYLPARABEN, PHENOXYETHANOL, POTASSIUM SORBATE, PROPYLPARABEN, IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

  • Uses

    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

    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 For Sunscreen Use

    Directions For Sunscreen Use:

    - Apply liberally 15 minutes before sun exposure
    - Reapply:

    - at least every 2 hours
    - use a water resistant sunscreen if swimming or sweating
    - 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.

  • DOSAGE & ADMINISTRATION

    As needed

  • INDICATIONS & USAGE

    Helps prevent sunburn

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed seek medical help or contact a Poison Control Center right away.

  • PURPOSE

    Sunscreen

  • carton art

    ceramide makeup

  • INGREDIENTS AND APPEARANCE
    CERAMIDE MAKEUP SPF 15 
    octinoxate, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10967-668
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TREHALOSE (UNII: B8WCK70T7I)  
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ALANINE (UNII: OF5P57N2ZX)  
    ALPINIA ZERUMBET LEAF (UNII: MS8P33AMKX)  
    ABELMOSCHUS MOSCHATUS SEED (UNII: UN2QZ55I88)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    ACETYL OCTAPEPTIDE-3 (UNII: 8K14HJF88S)  
    MANNITOL (UNII: 3OWL53L36A)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    UREA (UNII: 8W8T17847W)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICA (UNII: V8A1AW0880)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SORBITOL (UNII: 506T60A25R)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10967-668-0132 g in 1 JAR; Type 0: Not a Combination Product11/11/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/11/2015
    Labeler - REVLON (788820165)
    Registrant - REVLON (788820165)
    Establishment
    NameAddressID/FEIBusiness Operations
    Revlon809725570manufacture(10967-668)