Label: NON-NANO SUNSCREEN SPF 40- zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL

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 February 27, 2019

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  • ACTIVE INGREDIENT

    Zinc Oxide 17.5%

  • PURPOSE

    Sunscreen

  • USE

    • 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

    • For sunscreen use
    • apply liberally and evenly 15minutes before sun exposure
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • children under 6 months of age: Ask a doctor.
    • Sun Protection Measures: Spending time in the sun increasesyour 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 measuresincluding
    • limit time in the sun, especially from 10 a.m.–2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses.
  • OTHER INFORMATION

    • protect the product in this container from excessive heat and direct sun
    • may stain some fabrics
  • QUESTIONS?

    CALL 800.800.1200
    www.ProCapsLabs.com

  • INACTIVE INGREDIENTS

    Water (Aqua), Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Seed Oil, Cetearyl Alcohol, Silica, Coco-Glucoside, Microcrystalline Cellulose, Glycerin, Pyrus Malus (Apple) Fruit Extract, Cocoyl Proline, Humulus Lupulus (Hops) Extract, Isostearic Acid, Phenylpropanol, Polyhydroxystearic Acid, Xanthan Gum

  • PRINCIPAL DISPLAY PANEL

    606114-01U Sole_Box_6oz_MOCKUPwDIELINE

  • INGREDIENTS AND APPEARANCE
    NON-NANO SUNSCREEN  SPF 40
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72879-505
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION17.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    APPLE (UNII: B423VGH5S9)  
    COCOYL PROLINE (UNII: 0IH06971TF)  
    HOPS (UNII: 01G73H6H83)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72879-505-021 in 1 BOX03/29/2019
    159 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:72879-505-041 in 1 BOX03/29/2019
    2118 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:72879-505-061 in 1 BOX03/29/2019
    3177 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/29/2019
    Labeler - ProCaps Laboratories, Inc. (144872652)
    Establishment
    NameAddressID/FEIBusiness Operations
    Thibiant International, Inc.083913913manufacture(72879-505)
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