Astivita Face and Body Zinc Lotion Safe for Kids

WEAR ME TINTED HYDRATING FACIAL SUNSCREEN- zinc oxide cream
Veganic SKN Limited

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.

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WEAR ME TINTED HYDRATING FACIAL SUNSCREEN
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83252-005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 kg in 100 kg

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
COCONUT OIL (UNII: Q9L0O73W7L)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM HINOKITIOL (UNII: 5MPS47D679)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)
TOCOPHEROL (UNII: R0ZB2556P8)
JOJOBA OIL (UNII: 724GKU717M)
XANTHAN GUM (UNII: TTV12P4NEE)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CANDELILLA WAX (UNII: WL0328HX19)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83252-005-03	0.1 kg in 1 TUBE; Type 0: Not a Combination Product	02/27/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/27/2023

Labeler - Veganic SKN Limited (743536682)

Name	Address	ID/FEI	Business Operations
Establishment
Veganic SKN Limited		743536682	manufacture(83252-005) , pack(83252-005) , label(83252-005)