Label: SUNKIDS ANTI-MOZZIE SUNSCREEN- zinc oxide cream
- NDC Code(s): 83252-030-04
- 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 March 13, 2023
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INGREDIENTS AND APPEARANCE
SUNKIDS ANTI-MOZZIE SUNSCREEN
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83252-030 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 VANILLIN (UNII: CHI530446X) SUNFLOWER OIL (UNII: 3W1JG795YI) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) SODIUM CHLORIDE (UNII: 451W47IQ8X) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) JOJOBA OIL (UNII: 724GKU717M) TOCOPHEROL (UNII: R0ZB2556P8) CANDELILLA WAX (UNII: WL0328HX19) COCONUT OIL (UNII: Q9L0O73W7L) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) WATER (UNII: 059QF0KO0R) CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H) XANTHAN GUM (UNII: TTV12P4NEE) MALTODEXTRIN (UNII: 7CVR7L4A2D) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) SODIUM HINOKITIOL (UNII: 5MPS47D679) GLYCERIN (UNII: PDC6A3C0OX) FERROSOFERRIC OXIDE (UNII: XM0M87F357) CITRONELLA OIL (UNII: QYO8Q067D0) ISOSTEARIC ACID (UNII: X33R8U0062) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83252-030-04 0.1 kg in 1 TUBE; Type 0: Not a Combination Product 03/13/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/13/2023 Labeler - Veganic SKN Limited (743536682) Establishment Name Address ID/FEI Business Operations Veganic SKN Limited 743536682 manufacture(83252-030) , label(83252-030) , pack(83252-030)
