SOLAIRE PEAU PARFAITE 100% MINERAL FLUID FLAWLESS SKIN- zinc oxide, titanium dioxide lotion

Solaire Peau Parfaite 100% Mineral Fluid Flawless skin by

Drug Labeling and Warnings

Solaire Peau Parfaite 100% Mineral Fluid Flawless skin by is a Otc medication manufactured, distributed, or labeled by Autumn Harp, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Titanium Dioxide 2.5%

Zinc Oxide 7.2%

Purpose

Sunscreen

ACTIVE INGREDIENT

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:

• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time ​in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regulary use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m.-2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
• For use on children less than 6 months of age, consult a doctor.

Other information

• ​​protect the product in this container from excessive heat and direct sun

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

R12944_Tube_Approved_Proof_12.4.18.jpg

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

INGREDIENTS AND APPEARANCE

SOLAIRE PEAU PARFAITE 100% MINERAL FLUID FLAWLESS SKIN 
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0354
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.5 mg  in 100 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.2 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0354-1	1 in 1 CARTON	05/01/2019
1		3000 mg in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/07/2019

Labeler - Autumn Harp, Inc. (064187883)

Registrant - Autumn Harp, Inc. (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp, Inc.		064187883	manufacture(51514-0354)