NDC Code(s) : 58479-020-00, 58479-020-01
Packager : Crossing Cultures, LLC dba Goddess Garden

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

goddess garden ORGANICS Sport NATURAL SUNSCREEN SPF 30TITANIUM DIOXIDE, ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58479-020
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE64 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION60 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF(UNII: ZY81Z83H0X)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE(UNII: E00JL9G9K0)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
GLYCERYL STEARATE CITRATE(UNII: WH8T92A065)
STEARIC ACID(UNII: 4ELV7Z65AP)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58479-020-0029.6 mL in 1 TUBE Type 0: Not a Combination Product17/01/2015
2NDC:58479-020-01100 mL in 1 TUBE Type 0: Not a Combination Product17/01/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/17/2015 02/28/2018

PRINCIPAL DISPLAY PANEL

ORGANICS Sport NATURAL SUNSCREEN SPF 30 TUBE, 29.6ml