Label: NATURAL SUNSCREEN- zinc oxide cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 69788-000-01 - Packager: MooGoo USA LLC
- Category: HUMAN OTC DRUG LABEL
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 April 5, 2016
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
DOSAGE & ADMINISTRATION
Directions
Apply liberally 15 minutes before sun exposure
Reapply:
- after 40 minutes of swimming or sweating
- immediately after towel drying
- if rubbed off by clothing or water
Sun Protection Measures: This Zinc based sunscreen reflects and scatters more than 97% of UV rays. In addition to sunscreen, limit time in peak sun and wear a hat. All natural products should be patch tested before use.
- WARNINGS
- INACTIVE INGREDIENT
- LABEL
-
INGREDIENTS AND APPEARANCE
NATURAL SUNSCREEN
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69788-000 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:69788-000-01 120 g in 1 PACKAGE; Type 0: Not a Combination Product 04/05/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/07/2015 Labeler - MooGoo USA LLC (076343899) Establishment Name Address ID/FEI Business Operations MooGoo USA LLC 076343899 manufacture(69788-000)