Label: TRUE NATURAL BROAD SPECTRUM SPF 50 ALL NATURAL SUNSCREEN LIMITED EDITION- 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 March 19, 2012

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

  • Active Ingredient Section


    Drug Facts

    Active Ingredients


    Zinc Oxide 20 %


  • Purpose Section

    Purpose

    Sunscreen

  • Keep Out Of Reach Of Children Section

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

  • Uses Section

    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 Section


    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

    If product is swallowed, get medical help or contact a Poison Control Center right away.

    Non-Water Resistant Product
  • Directions Section

    Directions

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • 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 the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hat, and sunglasses
    • children under 6 months; Ask a doctor
  • Inactive Ingredient Section

    Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Beeswax, Caprylic/Capric Triglyceride, Coconut Oil, Deionized Water, Fragrance (natural), Glycerin, Hydrogenated Ethylhexyl Stearate/Ethylhexyl Olivate, Hydrogenated Olive/Olive Oil Unsaponifiables, p-Anisic Acid, Shea Butter, Silica, Sodium Lactate, Xanthan Gum, Yellow Iron Oxide

    Certified Organic Ingredients

  • Other Information Section

    Other Information

    Keep away from extreme heat or cold. This is a natural product and some separation may occur if product is left in these conditions.

  • Questions or Comments Section

    Questions or comments

    877.515.8783 or visit www.TrueNatural.com

  • Package label

    true natural broad spectrum spf 50  all natural sunscreen   Limited Edition   vanilla-coconut

    100% mineral based anti-aging for face goes on clear  1.7 fl oz / 50ml

    Meets TSA Carry-on Requirements   Made in the USA  ALL NATURAL 110% INGREDIENTS

    manufactured for true Natural 13611 NE 126th PL, #200. Kirkland WA 98034

    True Natural SPF 50 Face Label

  • INGREDIENTS AND APPEARANCE
    TRUE NATURAL BROAD SPECTRUM SPF 50  ALL NATURAL SUNSCREEN LIMITED EDITION
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76245-220
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYL OLEATE (UNII: R34927QY59)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76245-220-0150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/12/2012
    Labeler - True Nature Group, Inc. (968069307)
    Registrant - True Nature Group, Inc. (968069307)