MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide and titanium dioxide 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

Zinc Oxide - 18.6%

Helps prevent sunburn

if used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

For external use only.

do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

if product is swallowed, get medical help or contact a Poison Control Center right away.

apply liberally 20 minutes before sun exposure.

use a water resistant sunscreen if swimming or sweating.

reapply:

immidiately aftr swimming, sweating or towel drying.

at least every 2 hours.

children under 6months: ask doctor

Sun protection measures:

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protector measures including:

limit time in the sun, especially from 10:00 am to 2:00 pm.

wear long sleaved shirts, pants, hats and sun glasses.

May stain or damage some fabrics or surfaces. Avoid long term storage above 40C (120F). Protect the product in this container from excessive heat and direct sunlight.

Ascorbic Acid, Ascorbyl Palmitate, Acrylates/C10-3- Alkyl Acrylate Crosspolymer, Algae Extract, Artemesia Vulgaris Extract, Bisabolol, Butylene Glycol, C13-14 Isoparaffin, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglycerides, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Citral, Citric Acid, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dipotassium Glycyrrhizate, Disodium EDTA, Ethylhexylglycerin, Fragrance*, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Hexylene Glycol, Imperata Cylindrica Root Extract, Laureth-7, Lecithin, Limonene, PEG-100 Stearate, PEG-8, Phenoxyethanol, Polyacrylamide Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sorbitan Stearate, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Linoleate/Oleate, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Obiquinone, Water (Aqua), Xanthan Gum. 100% Natural 

Distributed By:

The Soleil Group, LLC.

Bronxville, NY 10708

Energie 43

1271 EC Huizen, Netherlands

www.soleiltoujours.com

MADE IN USA

Image MSBS 30

Image MSBS 30

MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 
zinc oxide and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4154
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION50.0 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)  
.BETA.-BISABOLOL (UNII: LP618AV2EA)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARBOMER 934 (UNII: Z135WT9208)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRAL (UNII: T7EU0O9VPP)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
LAURETH-7 (UNII: Z95S6G8201)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL LINOLEATE, D- (UNII: G0N132Q0ED)  
UBIQUINONE Q2 (UNII: I7T5V2W47R)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4154-21 in 1 CARTON12/12/2017
1NDC:62742-4154-194.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/12/2017
Labeler - Allure Labs, Inc (926831603)
Registrant - Allure Labs, Inc (926831603)
Establishment
NameAddressID/FEIBusiness Operations
Allure Labs, Inc926831603manufacture(62742-4154)

Revised: 12/2017
Document Id: 5d997894-d0e9-43f9-9b06-d3dfff865b40
Set id: a149b716-58f5-4da1-b330-f79fa7596c18
Version: 1
Effective Time: 20171212
 
Allure Labs, Inc