SOLAIRE PEAU PARFAITE 100 MINERAL SUNSCREEN- zinc oxide lotion

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
Available from:
Yves Rocher Amerique du Nord Inc
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- Helps prevent sunburn
Authorization status:
OTC monograph not final
Authorization number:
63505-770-00

SOLAIRE PEAU PARFAITE 100 MINERAL SUNSCREEN- zinc oxide lotion

Yves Rocher Amerique du Nord 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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Solaire Peau Parfaite- 100% Mineral Sunscreen

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:

SOLAIRE PEAU PARFAITE 100 MINERAL SUNSCREEN

zinc oxide lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 350 5-770

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)

ZINC CATION

144 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

CO CO -CAPRYLATE (UNII: 48 28 G8 36 N6 )

PO LYGLYCERYL-2 DIPO LYHYDRO XYSTEARATE (UNII: 9 229 XJ4V12)

DICAPRYLYL CARBO NATE (UNII: 6 0 9 A3V1SUA)

PO LYGLYCERYL-4 ISO STEARATE (UNII: 8 20 DPX33S7)

GLYCERIN (UNII: PDC6 A3C0 OX)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

STARCH, TAPIO CA (UNII: 24SC3U70 4I)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

MAGNESIUM SULFATE, UNSPECIFIED FO RM (UNII: DE0 8 0 37SAB)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

SILICA DIMETHYL SILYLATE (UNII: EU2PSP0 G0 W)

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

MATRICARIA CHAMO MILLA (UNII: G0 R4UBI2ZZ)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 350 5-770 -0 0

1 in 1 BOX

0 5/0 1/20 19

1

177 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 5/0 1/20 19

Yves Rocher Amerique du Nord Inc

Labeler -

Yves Rocher Amerique du Nord Inc (201826448)

Revised: 3/2019

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