Label: WAXHEAD TINTED ZINC OXIDE SUNSCREEN SPF 30- zinc oxide cream

  • 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 October 2, 2023

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  • Active Ingredients

    25% non-nano Zinc Oxide (USP, uncoated)

    Inactive Ingredients

    Virgin Coconut Oil (cocos nucifera seed oil), Beeswax (cera alba), Cocoa powder (theobroma cacao seed powder)
    (all Certified Organic by USDA/NOP)

  • Uses

    Helps prevent sunburn. If used as directed with other sun defense
    measures, decreases risk of skin cancer and aging caused by the sun

  • Directions

    Slowly push up product from bottom of tube, then apply and spread
    sunscreen in dots and stripes onto sections of face and body. (Retract
    into container by tapping bottom against a hard surface.)

    Reapply after 80 minutes of swimming or sweating, after towel drying,
    or at least every 2 hours.

    Other Sun Defense Measures
    Exposure to sun increases risk of skin cancer and skin aging. To decrease
    risk, regularly use sunscreen with broad spectrum SPF 30 or higher and:
    limit time in the sun, especially from 10 am - 2 pm, wear long sleeve shirt,
    pants, hat and sunglasses. Children under 6 months, ask a doctor.

  • Warnings

    For external use only. Keep product out of eyes. Rinse eyes with water.
    Do not use on damaged skin. Stop use and ask a doctor if rash develops.
    Keep out of reach of children. If swallowed, get medical help or contact a
    Poison Control Center immediately.

  • Other Info

    Protect this product from excessive heat and direct sun.

  • Questions?

    Contact Waxhead Sun Defense gowaxhead.com

  • Package Label

    Waxhead Tinted SPF 30 Label

  • INGREDIENTS AND APPEARANCE
    WAXHEAD TINTED ZINC OXIDE SUNSCREEN SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73369-1206
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L) 45 g  in 100 g
    YELLOW WAX (UNII: 2ZA36H0S2V) 15 g  in 100 g
    COCOA (UNII: D9108TZ9KG) 15 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73369-1206-1110 g in 1 TUBE; Type 0: Not a Combination Product04/15/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/15/2016
    Labeler - Kabana Skin Care (080237112)
    Registrant - Kabana Skin Care (080237112)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kabana Skin Care080237112manufacture(73369-1206)
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