FDA.reportPublic FDA data

AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE

Manufacturer
Codif International
Effective date
2021-12-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:23:20

Label at a glance#

ProductSOLEIL SUN Creme Solaire Visage et corps Sunscreen Face and Body Sunscreen Broad Spectrum SPF30
Active ingredientAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE
Label structure9 sections

Indications and uses

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

Dosage and administration

apply liberally 15 minutes before sun exposure reapply at least every two hours use a water resistant sunscreen if swimming or sweating Sun protections measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regurlarly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially fr...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.7%
Homosalate 7%
Octinoxate 6.7%
Octisalate 4.5%

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 sun 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 skin 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

OTC - STOP USE SECTION

if 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
  • reapply at least every two hours
  • use a water resistant sunscreen if swimming or sweating
  • Sun protections measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regurlarly 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

Other information

SPL UNCLASSIFIED SECTION

  • protect this product from excessive  heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, butyloctyl salicylate, ethylhexyl methoxycrylene, dicaprylyl carbonate, butylene glycol cocoate, glycerin, polyglyceryl-6 distearate, styrene/acrylates copolymer, jojoba esters, dimethicone, phenoxyethanol, potassium cetyl phosphate, fragrance, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, polyglyceryl-3 beeswax, xanthan gum, cetyl alcohol, chlorphenesin, peg-8 laurate, dimethiconol, 1,2-hexanediol, caprylyl glycol, disodium edta, polysorbate 60, sorbitan isostearate, sea salt, bht, tocopherol.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-227-8051

Package Labeling: (66846-015-01) 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Inner PackageInner Package

Outer PackageOuter Package

Package Labeling: (66846-015-04)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Inner Package 2Inner Package 2

Outer Package 2Outer Package 2

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66846-01566846-015-01, 66846-015-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
XANTHAN GUMTTV12P4NEEIACT
CETYL ALCOHOL936JST6JCNIACT
CHLORPHENESINI670DAL4SZIACT
PEG-8 LAURATE762O8IWA10IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
POLYSORBATE 60CAL22UVI4MIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
SEA SALT87GE52P74GIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
TOCOPHEROLR0ZB2556P8IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
GLYCERINPDC6A3C0OXIACT
POLYGLYCERYL-6 DISTEARATEZ35I17EQOPIACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT

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
d3092168-216e-2d9d-e053-2995a90ae02488d388be-a0d8-4df5-a2ed-322c4787a8a52021-12-13WarningsExact identifier
spl id: d3092168-216e-2d9d-e053-2995a90ae024
spl set id: 88d388be-a0d8-4df5-a2ed-322c4787a8a5

Reported adverse events (FAERS/openFDA)#

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