SOLAIRE PEAU PARFAITE 100 MINERAL SUNSCREEN- zinc oxide lotion

Solaire Peau Parfaite 100 Mineral Sunscreen by

Drug Labeling and Warnings

Solaire Peau Parfaite 100 Mineral Sunscreen 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

Zinc Oxide 14.4%

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 15 minutes before sun exposure  Reapply:  after 40 minutes of swimming or sweating immediately after towel drying  At least every 2 hours. 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 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.
• Store at 15-30°C (59-86°F)

Inactive ingredients

Water/Eau, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Coco-Caprylate, Polyglyceryl-2 Dipolyhydroxystearate, Dicaprylyl Carbonate, Polyglyceryl-4 Isostearate, Cetyl Dimethicone, Glycerin, Copernicia Cerifera (Carnauba) Wax/Cire de carnauba, Cetyl Alcohol, Euphorbia Cerifera (Candelilla) Wax/Cire de candelilla, Tapioca Starch, Phenoxyethanol, Magnesium Sulfate, Sodium Chloride, Stearic Acid, Chlorphenesin, Silica Dimethyl Silylate, Triethoxycaprylylsilane, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract.

Questions?

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

Package Labeling:

INGREDIENTS AND APPEARANCE

SOLAIRE PEAU PARFAITE 100 MINERAL SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63505-770
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	144 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCO-CAPRYLATE (UNII: 4828G836N6)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
STARCH, TAPIOCA (UNII: 24SC3U704I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
STEARIC ACID (UNII: 4ELV7Z65AP)
CHLORPHENESIN (UNII: I670DAL4SZ)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63505-770-00	1 in 1 BOX	05/01/2019
1		177 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)