OTC Medication Information: Solaire Peau Parfaite 100 Mineral Sunscreen

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.

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:

177mL Box
(click image for full-size original)
177mL Tube
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC CATION) ZINC CATION 144 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
DICAPRYLYL CARBONATE
POLYGLYCERYL-4 ISOSTEARATE
GLYCERIN
WATER
ALKYL (C12-15) BENZOATE
MEDIUM-CHAIN TRIGLYCERIDES
COCO-CAPRYLATE
CETYL ALCOHOL
STARCH, TAPIOCA
PHENOXYETHANOL
MAGNESIUM SULFATE, UNSPECIFIED FORM
SODIUM CHLORIDE
STEARIC ACID
CHLORPHENESIN
SILICA DIMETHYL SILYLATE
TRIETHOXYCAPRYLYLSILANE
ALOE VERA LEAF
MATRICARIA CHAMOMILLA
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63505-770-00 1 TUBE in 1 BOX contains a TUBE
1 177 mL in 1 TUBE This package is contained within the BOX (63505-770-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 05/01/2019 09/30/2021
Labeler — Yves Rocher Amerique du Nord Inc (201826448)

Revised: 09/2021 Yves Rocher Amerique du Nord Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.