Clarins Extra Firming Sunscreen Spf 15 Cream
FDA Label NDC 58668-9818

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Clarins for the product Clarins Extra Firming Sunscreen Spf 15 (NDC 58668-9818). 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 drug facts, active ingredients, purpose, uses:, warnings:, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

AVOBENZONE 3% 
HOMOSALATE 7%
OCTISALATE 5% 
OCTOCRYLENE 9%

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.

Do Not Use

  • on damaged or broken skin.

When Using This Product

  • keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor If

  • rash occurs.

Keep Out Of Reach Of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • apply liberally 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • children under 6 months: Ask a doctor
  • 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 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-sleeved shirts, pants, hats and sunglasses.
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating.

Inactive Ingredients:

AQUA/WATER/EAU. GLYCERIN. BUTYLOCTYL SALICYLATE. DIMETHICONE. PENTYLENE GLYCOL. CETEARYL ALCOHOL. NIACINAMIDE. ARGANIA SPINOSA KERNEL OIL. CELLULOSE. PARFUM/FRAGRANCE. POLYSILICONE-15. POTASSIUM CETYL PHOSPHATE. CETEARYL GLUCOSIDE. BUTYLENE GLYCOL. ACRYLATES/ C10-30 ALKYL ACRYLATE CROSSPOLYMER. HYDROXYACETOPHENONE. XANTHAN GUM. AVENA SATIVA (OAT) KERNEL EXTRACT. ETHYLHEXYLGLYCERIN. TOCOPHERYL ACETATE. ALOE BARBADENSIS LEAF JUICE POWDER. DISODIUM EDTA. SODIUM HYDROXIDE. PROPANEDIOL. CAPRYLIC/CAPRIC TRIGLYCERIDE. BETAINE. SORBITOL. MARRUBIUM VULGARE EXTRACT. MALTODEXTRIN. ORTHOSIPHON STAMINEUS EXTRACT. SODIUM BENZOATE. BALANITES ROXBURGHII SEED OIL. MITRACARPUS SCABER EXTRACT. PHENETHYL ALCOHOL. CARYA ILLINOINENSIS (PECAN) SHELL EXTRACT. FURCELLARIA LUMBRICALIS EXTRACT. CI 15985/YELLOW 6. LAPSANA COMMUNIS FLOWER/LEAF/ STEM EXTRACT. MARIS SAL/SEA SALT/SEL MARIN. ARGININE/LYSINE POLYPEPTIDE. [S4505A]

Other Information:

  • protect this product from excessive heat and direct sun.

Questions Or Comments?

Call 1-866-325-2746 Monday-Friday 9am to 6:30pm ET

* Please review the disclaimer below.