ZINCLEAR SPF 30 TINTED - zinc oxide cream 
Allure Labs Inc.

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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Drug Facts

Active Ingredient:

Zinc Oxide - 18.6%

Purpose:Sunscreen

Uses:

To help protect the skin from harmful UVA and UVB Rays

Warnings:

For External Use only

When using this product

Stop use and ask a doctor

Keep out of reach of children

Directions


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)

image description

ZINCLEAR SPF 30 TINTED 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4064
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE186 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4064-21 in 1 CARTON
1NDC:62742-4064-156.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/22/2014
Labeler - Allure Labs Inc. (926831603)

Revised: 4/2014
Document Id: 2aeda5d4-0cd2-4cd8-a12d-880ded11d9d2
Set id: 0a6ce431-7370-44ff-839c-6e42d3a5bc10
Version: 1
Effective Time: 20140421
 
Allure Labs Inc.