FDA.reportPublic FDA data

OCTINOXATE

Manufacturer
BPS 60
Effective date
2019-12-30
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 23:47:41

Label at a glance#

ProductTouche Eclat Le Teint Radiance Awakening Foundation Octinoxate Sunscreen Broad Spectrum SPF 22
Active ingredientOCTINOXATE
Label structure7 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

For sunscreen use: shake well before use apply generously 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 inc...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 6.8%

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 on

OTC - DO NOT USE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • shake well before use
  • apply generously 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cyclopentasiloxane, glycerin, dimethicone, isododecane, PEG-10 dimethicone, sorbitol, bis-PEG/PPG-14/14 dimethicone, synthetic fluorphlogopite, sodium chloride, silica, dimethicone/polyglycerin-3 crosspolymer, phenoxyethanol, methyl methacrylate crosspolymer, caprylyl glycol, disodium stearoyl glutamate, disteardimonium hectorite, silica siylate, tocopheryl acetate, ethyhexylglycerin, fragrance, aluminum hydroxide, ascorbyl palmitate, ethylhexyl hydroxystearate, triethoxycaprylylsilane, dipropylene glycol, ruscus aculeatus root extract, BHT, tocopherol, sodium citrate, isopropyl alcohol; may contain: titanium dioxide, iron oxides, bismuth oxychloride

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label7Label7

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70581-00270581-002-01

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
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
ISODODECANEA8289P68Y2IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
SORBITOL506T60A25RIACT
BIS-PEG/PPG-14/14 DIMETHICONEX2I70H0QJEIACT
SODIUM CHLORIDE451W47IQ8XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
DISODIUM STEAROYL GLUTAMATE45ASM2L11MIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
ASCORBYL PALMITATEQN83US2B0NIACT
ETHYLHEXYL HYDROXYSTEARATEB7I80BVV5EIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
DIPROPYLENE GLYCOLE107L85C40IACT
RUSCUS ACULEATUS ROOTZW12V95I1QIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
TOCOPHEROLR0ZB2556P8IACT
SODIUM CITRATE1Q73Q2JULRIACT
ISOPROPYL ALCOHOLND2M416302IACT
OCTINOXATE4Y5P7MUD51ACTIB

Source Document#

Source XML · Source PDF

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
0bc6c62f-ef85-7f8b-e063-6394a90a0d26c5dfd670-cfc4-4c92-9e7c-6c17b3c0709e2023-12-05WarningsExact identifier
spl set id: c5dfd670-cfc4-4c92-9e7c-6c17b3c0709e

Reported adverse events (FAERS/openFDA)#

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