Absolue Premium Bx Sunscreen Broad Spectrum Spf 15 Absolute Replenishing Cream
FDA Label NDC 70581-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bps 60 for the product Absolue Premium Bx Sunscreen Broad Spectrum Spf 15 Absolute Replenishing (NDC 70581-003). 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, 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%

Octisalate 3%

Octocrylene 8%

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

Directions

For sunscreen use:

  • apply generously and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor

Other Information

  • protect the product in this container from excessive heat and direct sun

Inactive Ingredients

water, glycerin, cyclohexasiloxane, alcohol denat., caprylic/capric triglyceride, PEG-20 methyl glucose sesquistearate, C12-15 alkyl benzoate, tocopheryl acetate, C13-14 isoparaffin, hydroxypropyl tetrahydropyrantriol, hydrolyzed malt extract, padina pavonica extract, hydrolyzed soy protein, stearic acid, adenosine, triethanolamine, polyacrylamide, calcium pantothenate, dimethyl isosorbide, limonene, xanthan gum, linalool, dioscorea villosa (wild yam) root extract, iron oxides, caprylyl glycol, capryloyl salicylic acid, paraffin, disodium EDTA, butylene glycol, cetyl alcohol, octyldodecanol, citronellol, laureth-7, hexyldecanol, fragrance

Questions Or Comments?

1-800-LANCOME (1-800-526-2663) Monday - Friday (9 a.m. - 5 p.m. EST)

Package Labeling:

Label6 (Label6)

Label6 (Label6)

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