SParms Organic Sports Sunscreen

SParms Organic Sports Sunscreen by

Drug Labeling and Warnings

SParms Organic Sports Sunscreen by is a Otc medication manufactured, distributed, or labeled by Veganic SKN Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPARMS ORGANIC SPORTS 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 Sports Sunscreen

SParms Organic Sports Sunscreen

SPARMS ORGANIC SPORTS SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83252-002
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CORIANDER OIL (UNII: 7626GC95E5)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CANDELILLA WAX (UNII: WL0328HX19)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
WATER (UNII: 059QF0KO0R)
JOJOBA OIL (UNII: 724GKU717M)
XANTHAN GUM (UNII: TTV12P4NEE)
ALUMINUM OXIDE (UNII: LMI26O6933)
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HINOKITIOL (UNII: 5MPS47D679)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83252-002-00	0.07 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/25/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/25/2023

Labeler - Veganic SKN Limited (743536682)

Establishment
Name	Address	ID/FEI	Business Operations
Veganic SKN Limited		743536682	pack(83252-002) , manufacture(83252-002) , label(83252-002)

Revised: 2/2023

Document Id: f3fd7667-9bc7-7761-e053-2a95a90a225a

34390-5

Set id: f30a97d9-84a6-3ddf-e053-2a95a90afecb

Version: 2

Effective Time: 20230205