Label: VERY EMOLLIENT BODY DAILY SHADE SPF15- avobenzone, homosalate, octisalate, octocrylene lotion

  • NDC Code(s): 61995-0371-1
  • Packager: The Hain Celestial Group
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2023

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  • ACTIVE INGREDIENT

    Avobenzone 2.5%

    Homosalate 7.5%

    Octisalate 5.0%

    Octocrylene 3.0%

  • PURPOSE

    Sunscreen

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    For sunscreen use, apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use water resistant sunscreen when swimming or sweating. 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 risk, regularly use a sunscreen with Broad Spectrum SPF 15 or higher and other protective measures, including: limit time in sun, especially 10am-2pm, and wear long-sleeved shirts, pants, hats and sunglasses.

  • 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 skin rash occurs.

  • DOSAGE & ADMINISTRATION

    For sunscreen use, apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use water resistant sunscreen when swimming or sweating. Children under 6 months: ask a doctor.

  • INACTIVE INGREDIENT

    Water (Aqua), Glycerin, Glyceryl Stearate SE, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, Sesamum Indicum (Sesame) Seed Oil, Butyrospermum Parkii (Shea) Butter, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil (1), Vitis Vinifera (Grape) Seed Oil, Aloe Barbadensis Leaf Juice (1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Cucumis Sativus (Cucumber) Fruit Extract, Echinacea Angustifolia Extract (1), Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract (1), Ascorbic Acid, Panthenol, Tocopheryl Acetate, Allantoin, Citric Acid, Glycolic Acid, Lactic Acid, Lecithin, Polysorbate 60, Potassium Hydroxide, Xanthan Gum, Alcohol (1), Benzoic Acid, Dehydroacetic Acid, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Amyl Cinnamal, Benzyl Alcohol, Benzyl Salicylate, Butylphenyl Methylpropional, Coumarin, Geraniol, Hexyl Cinnamal, Limonene, Linalool, Fragrance (Parfum)

  • PRINCIPAL DISPLAY PANEL

    PDP

  • INGREDIENTS AND APPEARANCE
    VERY EMOLLIENT BODY DAILY SHADE SPF15 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-0371
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    JOJOBA OIL (UNII: 724GKU717M)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE 100 (UNII: RO266O364U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    COUMARIN (UNII: A4VZ22K1WT)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
    LAVANDULA ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    ALLANTOIN (UNII: 344S277G0Z)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SESAME OIL (UNII: QX10HYY4QV)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    .ALPHA.-HEXYLCINNAMALDEHYDE, (2E)- (UNII: E9947QRR9O)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    GERANIOL (UNII: L837108USY)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
    CUCUMBER (UNII: YY7C30VXJT)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Colorwhite (White to pale off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-0371-1340 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/01/2019
    Labeler - The Hain Celestial Group (117115556)
    Registrant - The Hain Celestial Group (014334364)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group081512382manufacture(61995-0371)