AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE

Manufacturer
Laboratoires Clarins
Effective date
2019-01-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:32:05

Label at a glance#

ProductCLARINS BROAD SPECTRUM SPF 50 Dry Touch Facial Sunscreen Enriched with antioxidants Prevents sun induced age spots
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure10 sections

Indications and 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.

Dosage and administration

• 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...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE 3%

HOMOSALATE 10%

OCTISALATE 5%

OCTOCRYLENE 2.7%

OXYBENZONE 6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

• 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:

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

• 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

Other information:

SPL UNCLASSIFIED SECTION

• protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-866-252-7467 Monday-Friday, 8 a.m. to 5 p.m.

Inactive ingredients

INACTIVE INGREDIENT SECTION

AQUA/WATER/EAU . C12-15 ALKYL BENZOATE . BUTYLOCTYL SALICYLATE . DIPROPYLENE GLYCOL DIBENZOATE . BUTYLENE GLYCOL . ALCOHOL . ALUMINUM STARCH OCTENYLSUCCINATE . ALOE BARBADENSIS LEAF JUICE . PPG-15 STEARYL ETHER BENZOATE . MANNITOL . CETEARYL ALCOHOL . PARFUM/ FRAGRANCE . POTASSIUM CETYL PHOSPHATE . GLYCERIN . PHENOXYETHANOL . ACRYLATES/ C10-30 ALKYL ACRYLATE CROSSPOLYMER . CETEARYL GLUCOSIDE . DISODIUM EDTA . ETHYLHEXYLGLYCERIN . TOCOPHERYL ACETATE . XANTHAN GUM . TROMETHAMINE . TOCOPHEROL . CYCLODEXTRIN . PISUM SATIVUM (PEA) EXTRACT . CASSIA ALATA LEAF EXTRACT . FAEX EXTRACT/YEAST EXTRACT/EXTRAIT DE LEVURE . DEXTRIN . HYDROLYZED ADANSONIA DIGITATA EXTRACT . HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL . OLEA EUROPAEA (OLIVE) LEAF EXTRACT . PLATANUS OCCIDENTALIS BARK EXTRACT . CITRIC ACID . POTASSIUM SORBATE . SODIUM BENZOATE . BENZYL SALICYLATE . LIMONENE . BUTYLPHENYL METHYLPROPIONAL . HEXYL CINNAMAL . CITRONELLOL. [S1762A]

Package Labeling: (58668-3320-0)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package3Outer Package3Inner Package3Inner Package3

Package Labeling: (58668-3320-2)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TESTER3TESTER3

Package Labeling: (58668-3320-1)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package03Outer Package03Inner Package03Inner Package03

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58668-332058668-3320-0, 58668-3320-1, 58668-3320-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d053a1d2-3312-b4b9-e053-2995a90ace8cb75bf981-96a2-4368-8620-6e6b2cc12bf52021-11-08WarningsExact identifier
spl set id: b75bf981-96a2-4368-8620-6e6b2cc12bf5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.