Label: AMERICAN CREW ACUMEN MULTI DEFENSE MOISTURIZING SUNSCREEN- avobenzone, homosalate, octisalate lotion

  • 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 January 14, 2020

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  • Drug Facts

    Avobenzone 3.0%

    Homosalate 10.0%

    Octisalate 5.0%

  • Purpose

    Sunscreen

  • 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 is 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

    - repply:

    - 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 cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF or higher and other sun protection measures including:

    - limit time in the sun, especially from 10 a.m. to 2p.m.

    - wear long sleeve shirts, pants, hats and sunglasses

  • Storage

    - Protect this product from excessive heat and direct sun

    - Store at room temperature

  • Label

    acumen

  • INGREDIENTS AND APPEARANCE
    AMERICAN CREW ACUMEN MULTI DEFENSE MOISTURIZING SUNSCREEN 
    avobenzone, homosalate, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10967-659
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    LAURETH-7 (UNII: Z95S6G8201)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    GINGER (UNII: C5529G5JPQ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10967-659-1750 mL in 1 PACKAGE; Type 0: Not a Combination Product01/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/02/2020
    Labeler - Revlon Consumer Products Corporation (788820165)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab, Inc.080366903manufacture(10967-659)
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