Label: SPARMS ORGANIC SPORTS SUNSCREEN- zinc oxide cream
- NDC Code(s): 83252-002-00
- Packager: Veganic SKN Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 5, 2023
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INGREDIENTS AND APPEARANCE
SPARMS ORGANIC SPORTS SUNSCREEN
zinc oxide creamProduct 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)
