Label: ZINCLEAR SPF 30 TINTED- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 62742-4064-1, 62742-4064-2 - Packager: Allure Labs Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 April 21, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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INACTIVE INGREDIENT
Inactive Ingredients:
Water (Aqua), Cyclopentasiloxane, Butylene Glycol, Glycerin, Caprylic/Capric Triglyceride, Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxytethyl Dimethicone, Cyclohexasiloxane, Sorbitan Stearate, Dimethicone, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Caprylyl, Glycol, Ethylhexylglycerin, Hexylene Glycol, Imperata Cylindrica Root Extract, PEG-8, Carbomer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol, Lecithin, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Xanthan Gum, Polyester-7, Neopentyl Glycol Diheptanoate, Tocopheryl Linoleate/Oleate, Teprenone, Phoenix Dactylifera (Date) Fruit Extract, Polygonum Aviculare Extract, Sodium Lactate, Disodium EDTA, Dipotassium Glycrrihizate, Arabidopsis THaliana Extract, Plankton Extract, Micrococcus Lysate, Triethoxycaprylysilane, Iron Oxides (CI77491, CI77492, CI77499)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ZINCLEAR SPF 30 TINTED
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4064 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 186 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) DIMETHICONE (UNII: 92RU3N3Y1O) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CETYL ALCOHOL (UNII: 936JST6JCN) TOCOPHEROL (UNII: R0ZB2556P8) ASCORBYL PALMITATE (UNII: QN83US2B0N) ASCORBIC ACID (UNII: PQ6CK8PD0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) XANTHAN GUM (UNII: TTV12P4NEE) POLYESTER-7 (UNII: 0841698D2F) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) TEPRENONE (UNII: S8S8451A4O) DATE (UNII: H3O7QI5HY7) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) SODIUM LACTATE (UNII: TU7HW0W0QT) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) ARABIDOPSIS THALIANA (UNII: AI3L60HQ81) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4064-2 1 in 1 CARTON 1 NDC:62742-4064-1 56.7 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/22/2014 Labeler - Allure Labs Inc. (926831603)
