Label: YOUTH AGE DEFENSE MINERAL MOISTURIZER SPF 30- zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 20, 2017

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  • DRUG FACTS
  • ACTIVE INGREDIENT

    Zinc Oxide 21.0%

    PURPOSE

    Sunscreen

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  • USES

    • Helps prevent sunburn
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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 rash occurs

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • DIRECTIONS

    • Apply generously 15 minutes before sun exposure
    • Children under 6 months of age: Ask a doctor
    • Sun Protection Measures. Spending time in the sun increases the risk of skin cancer and early skin aging caused by the sun. 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 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
    • Reapply at least every 2 hours 
    • Use a water-resistant sunscreen if swimming or sweating
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  • OTHER INFORMATION

    • Protect the product in this container from excessive heat and direct sun
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  • INACTIVE INGREDIENTS

    Water, Jojoba Oil Esters, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea Butter) Oil, Jojoba Oil/Macadamia Seed Oil Esters,
    Tocopherol (Vitamin E), Tocopheryl Acetate (Vitamin E), Helianthus Annuus (Sunflower) Seed Oil, Glycine Soja (Soybean) Oil, Vitis Rotundifolia
    (Muscadine Grape) Fruit Extract, Magnesium Ascorbyl Phosphate (Vitamin C), Panthenol (Vitamin B5), Enteromorpha
    Compressa (Green Algae) Extract, Beta-Glucan, Caprylic/Capric Triglyceride (Fractionated Coconut Oil), Methyl Trimethicone, Dimethicone, Ethyl Macadamiate, Dextrin Palmitate, Sorbitan Sesquioleate, Stearyl Heptanoate, Olive Oil Polyglyceryl-6 Esters, Oleyl Erucate, Glycerin, Polyglyceryl-6 Pentaoleate, Eugenia Caryophyllus (Clove) Leaf Oil, Vitis Vinifera (Grape) Seed Extract, Cananga Odorata Flower Oil, Pisum Sativum (Pea) Extract, Alteromonas Ferment Extract, Acacia Decurrens Extract, Superoxide Dismutase, Caesalpinia Spinosa (Tara Tree) Gum, Isostearic Acid, Gluconolactone, 1,2-Hexanediol, Butylene Glycol, Caprylyl Glycol, Cetearyl Dimethicone Crosspolymer, Glyceryl Caprylate, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Lecithin, Magnesium Sulfate, Phytosterols, Phytosteryl Macadamiate, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Sodium Benzoate, Sodium Cocoyl Glutamate, Squalene, Sucrose Dilaurate, Coriandrum Sativum (Coriander) Fruit Oil

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  • Package Labeling:
  • INGREDIENTS AND APPEARANCE
    YOUTH AGE DEFENSE MINERAL MOISTURIZER SPF 30 
    zinc oxide lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59899-009
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 210 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    MUSCADINE GRAPE (UNII: 072T3X480E)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    STEARYL HEPTANOATE (UNII: 2M4UGL1NCN)  
    OLEYL ERUCATE (UNII: 753W099NQ6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CLOVE LEAF OIL (UNII: VCA5491KVF)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    CANANGA OIL (UNII: 8YOY78GNNX)  
    PEA (UNII: W4X7H8GYFM)  
    SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)  
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    SQUALENE (UNII: 7QWM220FJH)  
    SUCROSE DILAURATE (UNII: 5926LC4S7M)  
    CORIANDER OIL (UNII: 7626GC95E5)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59899-009-01 1 in 1 CARTON 08/09/2017
    1 50 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 08/09/2017
    Labeler - Shaklee Corporation (020284076)
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