VITAMIN E MOISTURE-PROTECT SPF 30 PA PLUS PLUS PLUS (OCTISALATE, HOMOSALATE, AVOBENZONE, OCTOCRYLENE, AND OCTINOXATE) LOTION [BUTH-NA-BODHAIGE, INC.,]

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  • VITAMIN E MOISTURE-PROTECT SPF 30 PA PLUS PLUS PLUS (OCTISALATE, HOMOSALATE, AVOBENZONE, OCTOCRYLENE, AND OCTINOXATE) LOTION [BUTH-NA-BODHAIGE, INC.,]

VITAMIN E MOISTURE-PROTECT SPF 30 PA PLUS PLUS PLUS (OCTISALATE, HOMOSALATE, AVOBENZONE, OCTOCRYLENE, AND OCTINOXATE) LOTION [BUTH-NA-BODHAIGE, INC.,]
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NDC 57691-970-50
Set ID 80f2f787-5e0a-4ea6-991a-323366c7c74a
Category HUMAN OTC DRUG LABEL
Packager Buth-Na-Bodhaige, Inc.,
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Avobenzone (3.0% w/w)Sunscreen
    Homosalate (8.0% w/w)Sunscreen
    Octinoxate (2.0% w/w)Sunscreen
    Octisalate (4.0% w/w)Sunscreen
    Octocrylene (7.0% w/w)Sunscreen
  • Uses

    • helps prevent sunburn.
  • 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 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.
    • 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 value of 15 or higher and other sun protection measures including:
      • limit time in sun especially from 10 a.m.– 2 p.m.
      • wear long sleeved shirts, pants, hats and sunglasses.
    • children under 6 months of age: ask a doctor.
  • Other information

    • protect the product in this container from excessive heat and direct sun.
  • Inactive Ingredients

    Water, Glycerin, Butylene Glycol, Dimethicone, Cetearyl Alcohol, Glyceryl Stearate, Magnesium Silicate, PEG-100 Stearate, Polymethylsilsesquioxane, Coco-Caprylate/Caprate, Phenoxyethanol, Polysorbate 60, Tocopheryl Acetate, Caprylyl Glycol, Triticum Vulgare (Wheat) Germ Oil, Polysilicone-11, Xanthan Gum, Fragrance, Aloe Barbadensis Leaf Juice Powder, Sodium Hyaluronate, Benzyl Benzoate, Potassium Sorbate, Disodium EDTA, Benzyl Alcohol, Hydroxycitronellal, Limonene, Geraniol, Linalool, Sodium Hydroxide, Citric Acid, Citronellol, Cinnamyl Alcohol, Decyl Glucoside, Alpha-Isomethyl Ionone, BHT, Isoeugenol, Hexylene Glycol.

  • PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

    THE
    BODY
    SHOP®

    THE BODY SHOP
    VITAMIN E

    MOISTURE-PROTECT
    EMULSION

    BROAD SPECTRUM
    SPF 30 SUNSCREEN

    WITH VITAMIN E & WHEATGERM OIL, & WITH
    BIOFERMENTED HYALURONIC ACID
    FROM POMACLE, FRANCE

    50 ml (1.69 US FL OZ)

    ALL SKIN TYPES

    Principal Display Panel - 50 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    VITAMIN E MOISTURE-PROTECT SPF 30 PA PLUS PLUS PLUS 
    octisalate, homosalate, avobenzone, octocrylene, and octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57691-970
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.04 g  in 1 mL
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate0.08 g  in 1 mL
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.03 g  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.07 g  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.02 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Magnesium Silicate (UNII: 9B9691B2N9)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)  
    Coco-Caprylate/Caprate (UNII: 8D9H4QU99H)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Wheat Germ Oil (UNII: 14C97E680P)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Benzyl Benzoate (UNII: N863NB338G)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Hydroxycitronellal (UNII: 8SQ0VA4YUR)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Geraniol (UNII: L837108USY)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Cinnamyl Alcohol (UNII: SS8YOP444F)  
    Decyl Glucoside (UNII: Z17H97EA6Y)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Isoeugenol (UNII: 5M0MWY797U)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57691-970-5050 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35212/15/2018
    Labeler - Buth-Na-Bodhaige, Inc., (791071279)
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