NDC Code(s) : 16047-0021-1
Packager : Sesderma USA LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Repaskids Facial / Body Broad Spectrum SPF50ZINC OXIDE, TITANIUM DIOXIDE GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16047-0021
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION170 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE111 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF(UNII: ZY81Z83H0X)
3-(TRIETHOXYSILYL)PROPYLAMINE(UNII: L8S6UBW552)
C12-15 ALKYL BENZOATE(UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
CERAMIDE EOP(UNII: 88KCS7120E)
CERAMIDE 3(UNII: 4370DF050B)
CHOLESTEROL(UNII: 97C5T2UQ7J)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
GLYCERYL ISOSTEARATE(UNII: HYE7O27HAO)
SOYBEAN(UNII: L7HT8F1ZOD)
ENOXOLONE(UNII: P540XA09DR)
ISOCETETH-10(UNII: 1K92T9919H)
PEG-30 DIPOLYHYDROXYSTEARATE(UNII: 9713Q0S7FO)
PHYTOSPHINGOSINE(UNII: GIN46U9Q2Q)
BEE POLLEN(UNII: 3729L8MA2C)
PROPANEDIOL(UNII: 5965N8W85T)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM LAUROYL LACTYLATE(UNII: 7243K85WFO)
STEARIC ACID(UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
WATER(UNII: 059QF0KO0R)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16047-0021-11 in 1 CARTON
1100 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/15/2015

PRINCIPAL DISPLAY PANEL

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