SOLAIRE PEAU PARFAITE 100% MINERAL FLUID FLAWLESS SKIN- zinc oxide, titanium dioxide lotion 
Autumn Harp, 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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Yves Rocher Solaire Peau Parfaite 100% Mineral Fluid Flawless Skin

Drug Facts

Active Ingredients

Titanium Dioxide 2.5%

Zinc Oxide 7.2%

Purpose

Sunscreen

Titanium Dioxide 2.5%

Zinc Oxide 7.2%

Uses

Helps prevent sunburn

Warnings

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.

Discontinue use and ask a doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply generously and evenly every morning on cleansed face and neck 15 minutes before sun exposure

For sunscreen use:

Other information

Inactive ingredients

water, ethylhexyl palmitate, caprylic/capric triglyceride, cyclopentasiloxane, diisopropyl sebacate, isonoyl isononanoate, polyglyceryl-6 polyricinoleate, polymethylsilsesquioxane, glycerin, argania spinosa kernel oil, polyglyceryl-2 isostearate, tocopheryl acetate, silica, caesalpinia spinosa fruit extract, vaccinium vitis-idaea fruit ectract, kappaphycus alvarezii extract, terminalia ferdinandiana fruit extract, chlorella vulgaris extract, aloe barbadensis leaf juice powder, raspberry seed oil/tocopheryl succinate aminopropanediol esters, olive oil decyl esters, hydrolyzed pea protein, sea salt, squalene*, saccharide isomerate, bisabolol, isopropyl myristate, hydrogenated castor oil, xanthan gum, gluconolactone, calcium gluconate, hydrated silica, tocopherol, sodium chloride, magnesium stearate, disteardimonium hectorite, stearalkonium hectorite, propylene carbonate, polyhydroxystearic acid, bentonite, alumina, isopropyl titanium triisostearate, lactic acid, citric acid, phenoxyethanol, potassium sorbate, sodium benzoate, mica, iron oxides (CI 77491, CI 77492, CI 77499), titanium dioxide (CI 77891).

* Botanically derived

Questions or comments?

Call: 1-800-321-3434

Principle Display Panel

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R12945_03809 UnC PL Fluide 100 Mineral Zero Defaut FPS30 30ml zan_vs12.jpg

Secondary artPrimary art

SOLAIRE PEAU PARFAITE 100% MINERAL FLUID FLAWLESS SKIN 
zinc oxide, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0354
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.5 mg  in 100 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.2 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CALCIUM GLUCONATE (UNII: SQE6VB453K)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
BENTONITE (UNII: A3N5ZCN45C)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SEA SALT (UNII: 87GE52P74G)  
POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)  
ARGAN OIL (UNII: 4V59G5UW9X)  
LINGONBERRY (UNII: 0UNK9RZQ7X)  
SQUALENE (UNII: 7QWM220FJH)  
LEVOMENOL (UNII: 24WE03BX2T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
LACTIC ACID, DL- (UNII: 3B8D35Y7S4)  
GLYCERIN (UNII: PDC6A3C0OX)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51514-0354-11 in 1 CARTON05/01/2019
13000 mg in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/07/2019
Labeler - Autumn Harp, Inc. (064187883)
Registrant - Autumn Harp, Inc. (064187883)
Establishment
NameAddressID/FEIBusiness Operations
Autumn Harp, Inc.064187883manufacture(51514-0354)

Revised: 2/2019
Document Id: 8154aef1-299a-6d90-e053-2a91aa0a0861
Set id: 8154aef1-2999-6d90-e053-2a91aa0a0861
Version: 1
Effective Time: 20190207
 
Autumn Harp, Inc.