SPF 30 MINERAL SUNSCREEN FACE NECK- 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 Ingredients: Zinc Oxide - 18.6%

Purpose: Sunscreen

Uses:

Warnings: For external use only.

When using this product keep out of eyes.Rinse with water to remove.

Stop use and ask a doctor if rash occurs. Do not use on damaged or broken skin.

Keep out of reach of children

Directions:

Other Information

Protect the product in this container from excessive heat and direct sun.

Water (Aqua), Cyclopentasiloxane, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Cyclohexasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sorbitan Stearate, Dimethicone, Cetyl Alcohol, Caprylic/Capric Triglyceride, Organic Butyrospermum Parkii (Shea) Butter, Polyacrylamide, C13-14 Isoparaffin, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Tocopheryl Linoleate/Oleate, Physalis Angulata Extract, Teprenone, Leontopodium Alpinum Meristem Cell Culture, Polygonum Aviculare Extract, Imperata Cylindrica Root Extract, Arabidopsis Thaliana Extract, Plankton Extract, Micrococcus Lysate, Organic Camellia Sinensis Leaf Extract, Phoenix Dactylifera (Date) Fruit Extract, Sidium Lactete, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Organic Aloe Barbadensis Leaf Juice, Lecithin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate-20, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Laureth-7, Xanthan Gum, Carbomer, PEG-8, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Disodium EDTA.

Made in USA

Distributed by OJAS, LLC

OjasSkin.com

Faceneck2ml

Faceneck50ml

SPF 30 MINERAL SUNSCREEN FACE NECK 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4086
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION186 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SHEA BUTTER (UNII: K49155WL9Y)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
TEPRENONE (UNII: S8S8451A4O)  
LEONTOPODIUM ALPINUM FLOWERING TOP (UNII: QQC1AK06RK)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
PHOENIX RECLINATA FRUIT (UNII: B140O227ZE)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LAURETH-7 (UNII: Z95S6G8201)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4086-12 mL in 1 TUBE; Type 0: Not a Combination Product07/14/2016
2NDC:62742-4086-31 in 1 CARTON07/14/2016
2NDC:62742-4086-250 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/11/2016
Labeler - Allure Labs Inc (926831603)
Establishment
NameAddressID/FEIBusiness Operations
Allure Labs Inc926831603manufacture(62742-4086)

Revised: 7/2016
Document Id: 27719a77-dbd8-4ee9-8424-8479c08b0504
Set id: 4f639436-d06f-45fb-9946-703d61e357b5
Version: 1
Effective Time: 20160711
 
Allure Labs Inc