Label: FITCOVER HYDRATING TINTED SUNSCREEN SPF50- zinc oxide cream
- NDC Code(s): 83252-004-11
- 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 22, 2023
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INGREDIENTS AND APPEARANCE
FITCOVER HYDRATING TINTED SUNSCREEN SPF50
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83252-004 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 FERROSOFERRIC OXIDE (UNII: XM0M87F357) SODIUM HINOKITIOL (UNII: 5MPS47D679) CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H) XANTHAN GUM (UNII: TTV12P4NEE) JOJOBA OIL (UNII: 724GKU717M) SUNFLOWER OIL (UNII: 3W1JG795YI) HYALURONIC ACID (UNII: S270N0TRQY) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) SODIUM CHLORIDE (UNII: 451W47IQ8X) CANDELILLA WAX (UNII: WL0328HX19) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) COCONUT OIL (UNII: Q9L0O73W7L) TOCOPHEROL (UNII: R0ZB2556P8) MALTODEXTRIN (UNII: 7CVR7L4A2D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83252-004-11 0.07 kg in 1 JAR; Type 0: Not a Combination Product 02/24/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/24/2023 Labeler - Veganic SKN Limited (743536682) Registrant - Veganic SKN Limited (743536682) Establishment Name Address ID/FEI Business Operations Veganic SKN Limited 743536682 manufacture(83252-004) , pack(83252-004) , label(83252-004)
