Label: ALMAY HEALTH GLOW 3-IN-1 MAKEUP SPF 20- octinoxate, titanium dioxide, zinc oxide kit

  • 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 October 22, 2019

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  • Active Ingredients:

    Octinoxate - 7.0%

    Titanium Dioxide 7.1%

    Zinc Oxide 4.2%

  • 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)), CYCLOPENTASILOXANE, DIMETHICONE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PHENYL TRIMETHICONE, POLYGLYCERYL-3 DIISOSTEARATE, GLYCERIN, BORON NITRIDE, TRIMETHYLSILOXYSILICATE, ALUMINA, DIMETHICONE/PEG-10/15 CROSSPOLYMER, BUTYLENE GLYCOL, SODIUM CHLORIDE, PHENOXYETHANOL, DISTEARDIMONIUM HECTORITE, TRIETHOXYCAPRYLYLSILANE, METHICONE, XANTHAN GUM, METHYLPARABEN, ETHYLPARABEN, TETRASODIUM EDTA, TOCOPHERYL ACETATE, DIPROPYLENE GLYCOL, SODIUM CITRATE, TOCOPHEROL, MELANIN, PENTYLENE GLYCOL

  • Principal Display Panel

    Almay

    Almay Health Glow 3-In-1 Makeup SPF 20

    Label

  • INGREDIENTS AND APPEARANCE
    ALMAY HEALTH GLOW 3-IN-1 MAKEUP SPF 20 
    octinoxate, titanium dioxide, zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0311-0711
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0311-0711-011 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package01/20/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1 1 
    Part 2 1 
    Part 1 of 2
    ALMAY HEALTH GLOW 3-IN-1 MAKEUP 
    octinoxate, titanium dioxide, zinc oxide liquid
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.128 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4.275 mg
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/20/2016
    Part 2 of 2
    ALMAY HEALTH GLOW 3-1 SELF TANNER 
    suntan gels, creams, and liquids liquid
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    INGRDIHYDROXYACETONE (UNII: O10DDW6JOO)  
    INGRPEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    INGRSILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPOLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    INGRTRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
    INGRCARAMEL (UNII: T9D99G2B1R)  
    INGRETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    INGRETHYLPARABEN (UNII: 14255EXE39)  
    INGRSODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRTOCOPHEROL (UNII: R0ZB2556P8)  
    INGRSODIUM CITRATE (UNII: 1Q73Q2JULR)  
    INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/20/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/20/2016
    Labeler - Almay, Inc. (064988652)
    Establishment
    NameAddressID/FEIBusiness Operations
    REVLON, INC.809725570manufacture(0311-0711)
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