Label: SPF30 DAILY MOISTURIZER WITH SUNSCREEN- spf30 moisturizer with zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 31, 2018

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  • Active Ingredient

    Zinc Oxide 22%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

  • Warnings

    For external use only

    Do not use

    Do not use on damaged or broken skin

    When using this product

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children

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

  • Directions

    • Apply generously 15 minutes before sun exposure
    • Reapply at least every 2 hours
    • Use a water-resistant sunscreen if 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 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, sepacially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
  • Inactive Ingredients

    Allantoin, Dimethicone, Ethylhexylglycerin, Fragrance, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isononyl Isononanoate, Jojoba Oil, Neopentyl Glycol Dicaprate, Niacinamide, Polyacrylamide, Polyisobutylene, Polysorbate 20, Polysorbate 60, Potassium Sorbate, Propanediol, Squalane, Tocopherol, Triethoxycaprylylsilane, Water

  • Other Information

    • protect this product from excessive heat and direct sun
  • Questions or Comments?

    Call toll-free 1-800-4016031

    www.prepyourskin.com

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  • INGREDIENTS AND APPEARANCE
    SPF30 DAILY MOISTURIZER WITH SUNSCREEN 
    spf30 moisturizer with zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70231-0020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE220 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SQUALANE (UNII: GW89575KF9)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ALLANTOIN (UNII: 344S277G0Z)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70231-0020-31 in 1 CARTON11/01/2016
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/01/2016
    Labeler - PREP Cosmetics LLC (053793815)
    Registrant - Richard Hamer Associates LLC (067731889)
    Establishment
    NameAddressID/FEIBusiness Operations
    TAKA USA Inc dba Cosmetic Innovations802860515manufacture(70231-0020) , pack(70231-0020)
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