SParms Organic Kids Sunscreen

SPARMS ORGANIC KIDS 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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SPARMS ORGANIC KIDS SUNSCREEN
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83252-003
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
XANTHAN GUM (UNII: TTV12P4NEE)
JOJOBA OIL (UNII: 724GKU717M)
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)
CORIANDER OIL (UNII: 7626GC95E5)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
GLYCERIN (UNII: PDC6A3C0OX)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HINOKITIOL (UNII: 5MPS47D679)
TOCOPHEROL (UNII: R0ZB2556P8)
AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CANDELILLA WAX (UNII: WL0328HX19)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83252-003-00	0.07 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/06/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/06/2023

Labeler - Veganic SKN Limited (743536682)

Name	Address	ID/FEI	Business Operations
Establishment
Veganic SKN Limited		743536682	manufacture(83252-003) , pack(83252-003) , label(83252-003)