WOLF DAILY MOISTURIZIER SPF 15 (OCTINOXATE, OXYBENZONE, ZINC OXIDE) LOTION [APOLLO HEALTH AND BEAUTY CARE INC.]

WOLF DAILY MOISTURIZIER SPF 15 (OCTINOXATE, OXYBENZONE, ZINC OXIDE) LOTION [APOLLO HEALTH AND BEAUTY CARE INC.]
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NDC 63148-008-04
Set ID 6f806d1d-c5f0-4a87-87f7-aa81033ae3b1
Category HUMAN OTC DRUG LABEL
Packager Apollo Health and Beauty Care Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Octinoxate 2%, Oxybenzone 4%, Zince Oxide 3.8%

    Purpose

    Sunscreen

  • Use(s)

    • 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 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.

  • Directions

    ​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 Broad Spectrum SPF value of 15 or higher and other sun protection measure including:

    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses.
    • use a water resistant sunscreen if swimming or sweating.
    • reapply at least every 2 hours.
    • children under 6 months: ask doctor
  • Other information

    Protect this product from excessive heat and direct sun.

  • Inactive ingredients

    Water (Aqua), Butylene Glycol Cocoate, Neopentyl Glycol Diheptanoate, Styrene/Acrylates Copolymer, Cetearyl Alcohol, Glycerin, Acetamidoethoxyethanol, Potassium Cetyl Phosphate, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Polysorbate 80, Isohexadecane, Benzyl Alcohol, Xanthan Gum, Tetrasodium Glutamate Diacetate, Fragrance (Parfum), Lactic Acid, Triethoxycaprylylsilane, Tetrahexydecyl Ascorbate, Crambe Abyssinica Seed Oil, Panthenol, Hydrolyzed Keratin, Camellia Sinensis Leaf Extract, Aspalathus Linearis Leaf Extract, Aloe Barbadensis Leaf Juice, Pinus Pinaster Bark Extract, Hydrolyzed Adansonia Digitata Seed Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Hydrolyzed Hemp Protein, Hydrolyzed Vegetable Protein, Ascorbyl Glucoside, Phytonadione, Niacinamide, Cyanocobalamin, Tocopheryl Acetate, Iodopropynyl Butylcarbamate.

  • Questions?

    Call toll-free 1-855-760-3569

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    WOLF DAILY MOISTURIZIER SPF 15 
    octinoxate, oxybenzone, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE20 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION38 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MARITIME PINE (UNII: 50JZ5Z98QY)  
    ADANSONIA DIGITATA SEED (UNII: 2936P60TPX)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CANNABIS SATIVA SEED (UNII: QE567Z26NG)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    PHYTONADIONE (UNII: A034SE7857)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CYANOCOBALAMIN (UNII: P6YC3EG204)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-008-04118 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2018
    Labeler - Apollo Health and Beauty Care Inc. (201901209)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(63148-008)

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