SOLAIRE PEAU PARFAITE 100 MINERAL FLUID FLAWLESS SKIN- titanium dioxide, zinc oxide 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 Yves Rocher Amerique du Nord Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Titanium Dioxide 2.5%,
Zinc Oxide 7.2%

Purpose

Sunscreen

Use

• 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, regularly 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 am - 2 pm wear 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.
• Store at 15-30°C (59-86°F)

Inactive ingredients

Water/Eau, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Diisopropyl Sebacate, Isononyl Isononanoate, Polyglyceryl-6 Polyricinoleate, Polymethylsilsesquioxane, Glycerin, Argania Spinosa Kernel Oil, Polyglyceryl-2 Isostearate, Tocopheryl Acetate,  Silica,  Phenoxyethanol, Disteardimonium Hectorite, Polyhydroxystearic Acid, Hydrogenated Castor Oil, Sodium Chloride, Magnesium Stearate, Bisabolol, Aloe Barbadensis Leaf Juice Powder, Alumina, Isopropyl Myristate, Raspberry Seed Oil Tocopheryl Succinate Aminopropanediol Esters, Caesalpinia Spinosa Fruit Extract, Bentonite, Vaccinium Vitis-Idaea Fruit Extract, Kappaphycus Alvarezii Extract, Hydrolyzed Pea Protein, Isopropyl Titanium Triisostearate, Stearalkonium Hectorite, Olive Oil Decyl Esters, Tocopherol, Citric Acid, Hydrated Silica, Propylene Carbonate, Lactic Acid, Terminalia Ferdinandiana Fruit Extract, Saccharide Isomerate, Squalene*, Xanthan Gum, Potassium Sorbate, Gluconolactone, Chlorella Vulgaris Extract, Sodium Benzoate, Sea Salt/Sel Marin, Calcium Gluconate, Mica, Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891). * Botanically derived Dérivé de plantes

Questions?

Call : CAN 1-800-361-2746 / USA 1 - 800-321-3434.

Package Labeling:

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63505-354
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	25 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	72 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
ARGAN OIL (UNII: 4V59G5UW9X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
LEVOMENOL (UNII: 24WE03BX2T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALUMINUM OXIDE (UNII: LMI26O6933)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
BENTONITE (UNII: A3N5ZCN45C)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)
TOCOPHEROL (UNII: R0ZB2556P8)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
LACTIC ACID (UNII: 33X04XA5AT)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
SQUALENE (UNII: 7QWM220FJH)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63505-354-00	1 in 1 BOX	05/01/2019
1		30 mL 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	05/01/2019

Labeler - Yves Rocher Amerique du Nord Inc (201826448)