Label: AMERICAN CREW ALL IN ONE FACE BALM BROAD SPECTRUM SPF 15- octisalate,homosalate,avobenzone,octocrylene liquid

  • NDC Code(s): 10967-651-24, 10967-651-51
  • Packager: Revlon Consumer Products Corp
  • 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 11, 2019

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  • Active Ingredients

    Octisalate 5.0%

    Homosalate 5.0%

    Avobenzone 2.0%

    Octocrylene 2.0%

  • 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 notuse 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 a 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
    •Use a water resistant sunscreen if swimming or sweating
    •Reapply at least every 2 hours
    •Children under 6 months: Ask a doctor.

  • 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 value of 15 or higher and other sun protection measures including:
    •Limit time in the sun, especially from 10 am - 2 pm
    •Wear long-sleeved shirts, pants, hats and sunglasses.

  • Inactive Ingredients

    Aqua/Water/Eau, C12-15 Alkyl Benzoate, Squalane,
    Glycerin, Dimethicone, Cetearyl Alcohol, Behentrimonium
    Chloride, Polyquaternium-37, Bisabolol, Panthenol,
    Hydroxyacetophenone, Glyceryl Dibehenate, Allantoin,
    Tocopheryl Acetate, Tribehenin, Glyceryl Behenate,
    Farnesol, Disodium EDTA, Sodium Citrate, Dipotassium
    Glycyrrhizate, Dimethicone Crosspolymer, Saccharide
    Isomerate, Parfum (Fragrance), Caprylyl Glycol,
    1,2-Hexanediol, Phenoxyethanol, Hydroxycitronellal,

  • Questions?

    1-800-598-2739

  • PRINCIPAL DISPLAY PANEL

    American Crew All in One Face Balm

    Broad Spectrum SPF 15

    170mL

    170ML

  • PRINCIPAL DISPLAY PANEL

    American Crew All in One Face Balm

    Broad Spectrum SPF 15

    50mL

    50mL

  • INGREDIENTS AND APPEARANCE
    AMERICAN CREW ALL IN ONE FACE BALM BROAD SPECTRUM SPF 15 
    octisalate,homosalate,avobenzone,octocrylene liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10967-651
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    SQUALANE (UNII: GW89575KF9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)  
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    4-HYDROXY ACETOPHENONE (UNII: G1L3HT4CMH)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    FARNESOL (UNII: EB41QIU6JL)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    EUGENOL (UNII: 3T8H1794QW)  
    GERANIOL (UNII: L837108USY)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    CITRAL (UNII: T7EU0O9VPP)  
    CINNAMYL ALCOHOL (UNII: SS8YOP444F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10967-651-51170 mL in 1 PACKAGE; Type 0: Not a Combination Product04/01/2017
    2NDC:10967-651-2450 mL in 1 PACKAGE; Type 0: Not a Combination Product04/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/01/2017
    Labeler - Revlon Consumer Products Corp (788820165)
    Establishment
    NameAddressID/FEIBusiness Operations
    REVLON, INC.809725570manufacture(10967-651)
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