SUNKIDS ANTI-MOZZIE 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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SunKids Anti-Mozzie Sunscreen

Label

SUNKIDS ANTI-MOZZIE SUNSCREEN
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83252-030
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
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83252-030-04	0.1 kg in 1 TUBE; Type 0: Not a Combination Product	03/13/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/13/2023

Labeler - Veganic SKN Limited (743536682)

Name	Address	ID/FEI	Business Operations
Establishment
Veganic SKN Limited		743536682	manufacture(83252-030) , label(83252-030) , pack(83252-030)

Revised: 3/2023

Document Id: f6c1b1ba-50f8-a256-e053-6394a90ac1d3

Set id: f5d04caa-860d-10d5-e053-2a95a90a9202

Version: 22

Effective Time: 20230313

Veganic SKN Limited