Protectyl Soleil Moisturizing Sunscreen Lotion High Protection Spf 30
FDA Label NDC 54235-204

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Yves Rocher North America Inc. Dba Laboratoire De Biologie Vegetal Yves Rocher for the product Protectyl Soleil Moisturizing Sunscreen Lotion High Protection Spf 30 (NDC 54235-204). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, otc - ask doctor, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Actives ingredients
Octinoxate 7.5%
Octocrylene 7.0%
Titanium dioxide 8.4%

Otc - Purpose

Purpose
Sunscreen

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

UsesHelps prevent sunburn. Higher SPF gives more sunburn protection.

Warnings

Warnings:
For external use only. When using this product, keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash and irritation develops and lasts.

Dosage & Administration

Directions:
Apply liberally 15 to 30 minutes before sun exposure and as needed. Reapply as needed
or after towel drying, swimming, perspiring heavily or washing.

Otc - Ask Doctor

Children under 6 months of age: ask a doctor.

Inactive Ingredient

Inactive ingredients:
ACER SACCHARINUM (SUGAR MAPLE) EXTRACT - ALLANTOIN - ALUMINA - ALUMINUM STEARATE - BUTYLENE GLYCOL - BUTYLPARABEN - C12-15 ALKYL BENZOATE - CYCLOHEXASILOXANE - CYCLOPENTASILOXANE - DIMETHICONE - DIMETHICONE CROSSPOLYMER - ETHYLPARABEN - FRAGRANCE (PARFUM) - GLYCERIN - CLYCERYL STEARATE - HYDROGENATED DIMER DILINOLEYL / DIMETHYLCARBONATE COPOLYMER - HUDROXYETHYLCELLULOSE - MANGIFERIN - METHYLPARABEN - METHYLPROPANEDIOL - PEG-100 STEARATE - PHENOXYETHANOL - POLYHYDROXYSTEARIC ACID - PROPYLENE GLYCOL - PROPYLPARABEN - SILICA - SORBITAN STEARATE - STEARETH-100 - TETRASODIUM EDTA - TOCOPHERYL ACETATE - VP/EICOSENE COPOLYMER - WATER (AQUA) - XANTHAN GUM

Package Label.Principal Display Panel

Protectyl Soleil

Moisturizing Sunscreen Lotion
High Protection SPF30

150 ml     5 fl.oz.




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