SOLAIRE PEAU PARFAITE MINERAL SCREEN SPF 30- zinc oxide cream

Solaire peau Parfaite Mineral Screen SPF 30 by

Drug Labeling and Warnings

Solaire peau Parfaite Mineral Screen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Yves Rocher North America Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide 19 %

Purpose

Sunscreen

Use

Helps prevent sunburn

Warnings

For external use only

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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

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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, Coco-Caprylate, Caprylic/ Capric Triglyceride, Cetearyl Isononanoate, Ethylhexyl Palmitate, Glycerin, Isopropyl Palmitate, Polyglyceryl-4 Diisostearate/ Polyhydroxystearate/Sebacate, Isopropyl Myristate, Magnesium Sulfate, Tocopherol, Polyglyceryl-3 Polyricinoleate, Decylene Glycol, Camellia Sinensis Leaf Extract, Lecithin, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunfl ower) Seed Oil, 1,2-Hexanediol, Xanthan Gum, Hydrogenated Castor Oil, Euphorbia Cerifera (Candelilla) Wax/Euphorbia Cerifera Cera/Cire de candelilla, Sodium Chloride, Isostearic Acid, Silica, Polyhydroxystearic Acid, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Citric Acid.

Questions?

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

Package Labeling:

INGREDIENTS AND APPEARANCE

SOLAIRE PEAU PARFAITE MINERAL SCREEN SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63505-771
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	190 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCO-CAPRYLATE (UNII: 4828G836N6)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
TOCOPHEROL (UNII: R0ZB2556P8)
DECYLENE GLYCOL (UNII: S57M60MI88)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SUNFLOWER OIL (UNII: 3W1JG795YI)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
CANDELILLA WAX (UNII: WL0328HX19)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOSTEARIC ACID (UNII: X33R8U0062)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63505-771-00	1 in 1 CARTON	09/01/2022
1		148 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 Drug	M020	09/01/2022

Labeler - Yves Rocher North America Inc. (201826448)