SParms Organic Sensitive Skin Facial Sunscreen

SPARMS ORGANIC SENSITIVE SKIN 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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SPARMS ORGANIC SENSITIVE SKIN FACIAL SUNSCREEN
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83252-001
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
TOCOPHEROL (UNII: R0ZB2556P8)
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CORIANDER OIL (UNII: 7626GC95E5)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
CANDELILLA WAX (UNII: WL0328HX19)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
JOJOBA OIL (UNII: 724GKU717M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM HINOKITIOL (UNII: 5MPS47D679)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83252-001-00	0.07 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/24/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/24/2023

Labeler - Veganic SKN Limited (743536682)

Name	Address	ID/FEI	Business Operations
Establishment
Veganic SKN Limited		743536682	manufacture(83252-001) , pack(83252-001) , label(83252-001)