Label: WAXHEAD BABY SUNSCREEN SPF 35- sunscreen 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

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredients

    25% Non-Nano Zinc Oxide (Uncoated, French Process)

    Purpose

    Sunscreen

  • Inactive Ingredients

    Spring water (aqua), Extra virgin olive oil* (oleo europaea fruit oil), Beeswax* (cera alba), Non-GMO Vegetable Vitamin E (tocopherol), Vitamin D3 (cholecalciferol). *Certified Organic by USDA/NOP

  • Uses

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

  • Warnings

    For external use only. Keep product out of eyes. Rinse with water to
    remove. 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.

  • Directions

    ​Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of
    swimming or sweating, immediately after towel drying, or every 2 hours.


    Sun Protection Measures. Exposure to sun increases risk of skin cancer
    and skin aging. To decrease risk, regularly use sunscreen with broad
    spectrum SPF 15 or higher and other sun defense measures including:
    limit time in the sun, especially from 10 AM to 2 PM, wear long sleeve
    shirts, pants, hats and sunglasses. Children under 6 months, ask a doctor.

  • Other Information

    Keep this product away excessive heat and direct sun. Shake before use.

  • Questions?

    Contact Waxhead Sun Defense gowaxhead.com.

  • Package Label

    Waxhead Baby SPF 30

  • INGREDIENTS AND APPEARANCE
    WAXHEAD BABY SUNSCREEN SPF 35 
    sunscreen cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73369-1204
    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
    YELLOW WAX (UNII: 2ZA36H0S2V) 4.75 g  in 100 g
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) 1.25 g  in 100 g
    WATER (UNII: 059QF0KO0R) 2 g  in 100 g
    OLIVE OIL (UNII: 6UYK2W1W1E) 67 g  in 100 g
    CHOLECALCIFEROL (UNII: 1C6V77QF41) 0.000000335 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73369-1204-1115 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(73369-1204)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!