Label: FLAWLESS FUTURE SPF 30- octinoxate, octisalate, oxybenzone, avaobenzone emulsion

  • 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

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  • ACTIVE INGREDIENTS

    OCTINOXATE 7.14%

    OCTISALATE 4.75%

    OXYBENZONE 4.00%

    AVOBENZONE 3.00%

  • OTHER INGREDIENTS

    WATER/AQUA/EAU, GLYCERIN, DIMETHICONE, ARGANIA SPINOSA KERNEL OIL, C12-15 ALKYL BENZOATE, TOCOPHERYL ACETATE, BUTYLENE GLYCOL, GLYCERYL STEARATE, PEG-100 STEARATE, CYCLOPENTASILOXANE, CETYL ALCOHOL, STEARYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, ADENOSINE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, BISABOLOL, CAPRYLYL GLYCOL, CARAMEL, CARBOMER, CERAMIDE 1, CERAMIDE 3, CERAMIDE 6 II, CHOLESTEROL, DIPOTASSIUM GLYCYRRHIZATE, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, FUCOSE, GLUCOSE, GLUCURONIC ACID, HYDROLYZED SOY PROTEIN, HYDROLYZED YEAST PROTEIN, JOJOBA ESTERS, KEFIRAN, PANTHENOL, PARFUM/FRAGRANCE, PHYTOSPHINGOSINE, PROPYLENE GLYCOL, SODIUM HYALURONATE, SODIUM LAUROYL LACTYLATE, TOCOPHEROL, XANTHAN GUM, BHT, ALPHA-ISOMETHYL IONONE, BENZYL SALICYLATE, BUTYLPHENYL METHYLPROPIONAL, CITRONELLOL, GERANIOL, HEXYL CINNAMAL, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, LIMONENE, LINALOOL, CHLORPHENESIN, PHENOXYETHANOL, SODIUM BENZOATE, RED 40 (CI 16035)

  • 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 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.
  • CARTON ART

    DRUG FACTS

  • INGREDIENTS AND APPEARANCE
    FLAWLESS FUTURE SPF 30 
    octinoxate, octisalate, oxybenzone, avaobenzone emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10967-683
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.14 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.75 mg  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    KEFIRAN (UNII: 8L821V6V99)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARAMEL (UNII: T9D99G2B1R)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    FUCOSE (UNII: 28RYY2IV3F)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ADENOSINE (UNII: K72T3FS567)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    GERANIOL (UNII: L837108USY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10967-683-1750 g in 1 JAR; Type 0: Not a Combination Product02/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/06/2017
    Labeler - REVLON (788820165)
    Registrant - REVLON (788820165)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab. INC.080987545manufacture(10967-683)