Label: FLESH HYDRATING SPF SERUM- avobenzone, homosalate, octisalate lotion

  • Category: HUMAN OTC DRUG LABEL

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 April 1, 2020

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  • Drug Facts

    Avobenzone 3.0%

    Homosalate 10.0%

    Octisalate 5.0%

  • Purpose

    Sunscreen

  • Uses

    - Helps prevent submburn

    - If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancerand early skin aging caused by the sun.

  • Warnings

    - For external use only

    - Do not use on danaged 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 swallowed get medical helpor contact a Poison Control Center right away.

  • Directions

    - Apply liberally 15 minutes before sun exposure

    - Use a water resistant sunscreen if swimming or sweating

    - Reapply at least every 2 hours

  • Other Information

    Protect this product from excessive heat and direct sun

  • Package

    Flesh SPF serum

  • INGREDIENTS AND APPEARANCE
    FLESH HYDRATING SPF SERUM 
    avobenzone, homosalate, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10967-660
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HONEY (UNII: Y9H1V576FH)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    UREA (UNII: 8W8T17847W)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    ORNITHINE HYDROCHLORIDE (UNII: HBK84K66XH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    WATER (UNII: 059QF0KO0R)  
    ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10967-660-0130 mL in 1 PACKAGE; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/01/2020
    Labeler - Revlon Consumer Products Corporation (788820165)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab, Inc.080366903manufacture(10967-660)
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