PAMELA METAMORPHOSIS SUNSCREEN SPF 30 (OCTINOXATE, ZINC OXIDE) CREAM [PAMELA METAMORPHISIS, INC.]

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PAMELA METAMORPHOSIS SUNSCREEN SPF 30 (OCTINOXATE, ZINC OXIDE) CREAM [PAMELA METAMORPHISIS, INC.]
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NDC 71048-100-02
Set ID 40e1d655-611c-2207-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Pamela Metamorphisis, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Drug Facts

  • Active Ingredients

    Octinoxate 7.50%

    Zinc Oxide 5.00%

    Purpose

    Sunscreen

  • Uses

    • 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 using and consult physician

    if irritation or rash develops.

    Keep out of reach of children.

    If product is swallowed, get medical attention or contact poison control center immediately.

  • Directions

    • Apply liberally 15-minutes before sun exposure.
    • Reapply:
    • At least every two-hours.
    • Immediately after swimming, sweating or towel drying. 
    • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection measures including:
    • Limit time in the sun, especially between 10am and 2pm
    • Wear long sleeve shirts, pants, hats and sunglasses.
    • For children under 6-months, consult a physician.
  • Other Ingredients

    Acrylamide/Sodium Acryloyldimethyl Taurate Copolymer, Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butylene Glycol, Caprylic/Capric Triglyceride, Cocamidopropyl Betaine, Cyclopentasiloxane, Cyclotetrasiloxante, DEA Oleth-10 Phosphate, Hyaluronic Acid, Isohexadecane, Lactic Acid, Niacinamide, Octyldodecyl Neopantanoate, Phenoxyethanol, Polysorbate-80, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Popanediol.

  • Other Information:

    • Protect this product from excessive heat and direct sunlight.
  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    PAMELA METAMORPHOSIS SUNSCREEN SPF 30 
    octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71048-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIETHANOLAMINE OLETH-10 PHOSPHATE (UNII: 55HSP2Q1LM)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71048-100-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product11/09/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/09/2016
    Labeler - Pamela Metamorphisis, Inc. (080403620)
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