Cle De Peau Beaute Concealer N Stick
FDA Label NDC 58411-665

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shiseido Americas Corporation for the product Cle De Peau Beaute Concealer N (NDC 58411-665). 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 other, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Otc - Do Not Use

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredients

→ Other Information

→ Questions Or Comments?

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Other

Drug Facts

Active Ingredients

TITANIUM DIOXIDE 1.6%

Purpose

Sunscreen

Uses

helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

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

Directions

For sunscreen use:

apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
reapply 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 of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor

Inactive Ingredients

HYDROGENATED POLYDECENE•DIMETHICONE•KAOLIN•NEOPENTYL GLYCOL DIHEPTANOATE•DIPHENYLSILOXY PHENYL TRIMETHICONE•LITHIUM MAGNESIUM SODIUM SILICATE•POLYETHYLENE•PARAFFIN•COPERNICIA CERIFERA (CARNAUBA) WAX•SORBITAN SESQUIISOSTEARATE•MICROCRYSTALLINE WAX•GLYCERIN•BARIUM SULFATE•PHYTOSTERYL MACADAMIATE•ARGANIA SPINOSA KERNEL OIL•TOCOPHERYL ACETATE•SODIUM ACETYLATED HYALURONATE•ROSA ROXBURGHII FRUIT EXTRACT•ZINGIBER AROMATICUS EXTRACT•ALUMINUM HYDROXIDE•DIPROPYLENE GLYCOL•PEG-10 DIMETHICONE•WATER•STEARIC ACID•ALCOHOL•BUTYLENE GLYCOL•TOCOPHEROL•SIMETHICONE•BHT•CHLORPHENESIN•FRAGRANCE•TITANIUM DIOXIDE•IRON OXIDES•MICA•