Label: NATIVE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 COCONUT AND PINEAPPLE- 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 May 23, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    ZINC OXIDE 20%

    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 use and ask a doctor if

    • rash occurs

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

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use water resistant sunscreen if swimming or sweating
    • 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 sun, especially from 10 a.m. – 2 p.m.
      • wear long-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months: ask a doctor
  • Other information

    • protect this product from excessive heat and direct sun
  • Inactive ingredients

    water, caprylic/capric triglyceride, coconut alkanes, glycerin, cetearyl alcohol, coco-glucoside, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, polyhydroxystearic acid, benzyl alcohol, xanthan gum, coco-caprylate/caprate, fragrance, tocopherol, helianthus annuus (sunflower) seed oil

  • SPL UNCLASSIFIED SECTION

    Distr. by Native San Francisco, CA 94111

  • Questions or comments?

    Please contact support@nativecos.com

  • PRINCIPAL DISPLAY PANEL - 147 mL Tube

    COCONUT AND PINEAPPLE

    NO OXYBENZONE

    NO OCTINOXATE

    NATIVE

    MINERAL SUNSCREEN

    SUNSCREEN WITH

    ZINC OXIDE

    BROAD SPECTRUM

    SPF 30

    5 FL OZ (147 mL)

    Native

  • INGREDIENTS AND APPEARANCE
    NATIVE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 COCONUT AND PINEAPPLE 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-552
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-552-14147 mL in 1 TUBE; Type 0: Not a Combination Product04/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2021
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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