Label: PLANT AND MINERAL SUNSCREEN SPF 50- 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 September 13, 2021

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  • ACTIVE INGREDIENTS

    20.2% ZINC OXIDE (non-nano)

  • PURPOSE

    Sunscreen

  • USES

    Helps prevent sunburn

  • Skin Cancer/Skin Aging Alert:

    Spending time sun may increase your risk of skin cancer and ealry skin aging. For external use only. Do not use on broken or damaged 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

    • Apply liberally 15 minutes before sun exposure
    •  Children under 6 months of age: Ask a doctor
    • At least every 2 hours
  • OTHER INFORMATION

    • Protect this product in this container from excessive heat and direct sun. Sore at temperatures below 90F.
  • INACTIVE INGREDIENTS

    Caprylic/Capric Triglyceride (MCT) Oil, Shorea Stenoptera (Illipe) Butter, Organic Ricinus Communis L. (Castor) Seed Oil, Butyrospermum Parkii (Shea) Butter, Oryza Sativa (Rice) Bran Wax, Organic Rubus Idaeus (Raspberry) Seed Oil, Persea Gratissima (Avocado) Oil, Citrullus Vulgaris (Watermelon) Seed, Organic Mentha Piperita (Peppermint) Oil, Non-GMO Tocopherol (Vitamin E)

  • PRINCIPAL DISPLAY PANEL

    SKIN NOURISHMENT PLANT AND MINERAL SUNSCREEN SPF 50 LOTION.jpg

  • INGREDIENTS AND APPEARANCE
    PLANT AND MINERAL SUNSCREEN  SPF 50
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82233-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SHOREA STENOPTERA SEED BUTTER (UNII: 129R0X862G)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    RICE BRAN (UNII: R60QEP13IC)  
    ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
    RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    WATERMELON SEED OIL (UNII: L33J06UQTT)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82233-101-1188 mL in 1 BOTTLE; Type 0: Not a Combination Product09/13/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/08/2021
    Labeler - SKINourishment, LLC. (033717744)
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