J0832706 JASON SUN FACIAL SUNSCREEN SPF20 (HOMOSALATE, OCTYL SALICYLATE, OCTOCRYLENE, AVOBENZONE) LOTION [THE HAIN CELESTIAL GROUP, INC.]

J0832706 JASON SUN FACIAL SUNSCREEN SPF20 (HOMOSALATE, OCTYL SALICYLATE, OCTOCRYLENE, AVOBENZONE) LOTION [THE HAIN CELESTIAL GROUP, INC.]
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NDC 61995-0027-4
Set ID 6249ff87-5a87-1451-e053-2a91aa0aeadd
Category HUMAN OTC DRUG LABEL
Packager The Hain Celestial Group, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredient

    Avobenzone - 2.0%

    Homosalate - 7.5%

    Octocrylene -5.0%

    Octyl Salicylate - 3.0%

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  • DOSAGE & ADMINISTRATION

    Apply liberally 15 minutes before sun exposure.Use a water resistant sunscreenif swimming or sweating. Reapply at least every 2 hours. Children under 6 months, ask a doctor

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  • PURPOSE

    Sunscreen

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  • 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.

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • INACTIVE INGREDIENT

    Water, Cetyl Alcohol, Glycerin, Caprylic/Capric Triglyceride, Glyceryl Stearate SE, Dimethicone, VP/Hexadecene Copolymer, Aloe Barbadensis Leaf Juice(1), CalenduCamellia Sinensis Leaf Extract (1), ChamoVitis Venifera (Grape) Seed Extract (1), Tocopheryl Acetate, Cetearyl Olivate, Citric Acid, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Xanthan Gum, Alcohol (1), Potassium Sorbate, Sodium Benzoate, BenDehydroacetic Acid, Phenoxyethanol.

    (1) Certified Organic Ingredient

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  • INDICATIONS & USAGE

    Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases.

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  • INGREDIENTS AND APPEARANCE
    J0832706 JASON SUN FACIAL SUNSCREEN SPF20 
    homosalate, octyl salicylate, octocrylene, avobenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-0027
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61995-0027-4 128 g in 1 BOTTLE; Type 0: Not a Combination Product 06/20/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 06/20/2017
    Labeler - The Hain Celestial Group, Inc. (858894996)
    Registrant - The Hain Celestial Group, Inc. (858894996)
    Establishment
    Name Address ID/FEI Business Operations
    The Hain Celestial Group, Inc. 014334364 manufacture(61995-0027)
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