Label: NATURAL SUNSCREEN- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70315-000-02 - Packager: A Bit Hippy
- 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 May 12, 2016
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
DIRECTIONS
Apply a nice even cover of sunscreen.
Initially it will be white.
Allow it to warm to skin temperature, then massage in until clear.
Natural protection is best, so always wear a cool looking hat and sunnies and avoid prolonged sun exposure.
Just like natural foods, natural skin care should be tested for allergies first. - WARNINGS
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NATURAL SUNSCREEN
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70315-000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 24.96 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) JOJOBA OIL (UNII: 724GKU717M) GALACTOARABINAN (UNII: SL4SX1O487) YELLOW WAX (UNII: 2ZA36H0S2V) COCO-CAPRYLATE (UNII: 4828G836N6) SORBITAN OLIVATE (UNII: MDL271E3GR) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CETYL PHOSPHATE (UNII: VT07D6X67O) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) OLEIC ACID (UNII: 2UMI9U37CP) GLYCERIN (UNII: PDC6A3C0OX) TROPOLONE (UNII: 7L6DL16P1T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70315-000-02 120 g in 1 PACKAGE; Type 0: Not a Combination Product 01/19/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/07/2015 Labeler - A Bit Hippy (080055273) Establishment Name Address ID/FEI Business Operations A Bit Hippy 080055273 manufacture(70315-000)