Drug Facts

Manufacturer
Cosmetique Active Production
Effective date
2024-01-15
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:07:19

Label at a glance#

ProductLa Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Sunscreen Broad Spectrum SPF 50
Active ingredientTITANIUM DIOXIDE
Label structure13 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: - after 40 minutes of swimming or sweating - immediately after towel drying - at least every 2 hours 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 oth...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 11%

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 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:

- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours

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 meausures 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, isododecane, C12-15 alkyl benzoate, dimethicone, undecane, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, nylon-12, caprylyl methicone, butyloctyl salicylate, phenethyl benzoate, silica, tridecane, dicaprylyl carbonate, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum stearate, pentylene glycol, C9-15 fluoroalcohol phosphate, tocopherol, phenoxyethanol, stearic acid, diethylhexyl syringylidenemalonate, PEG-9 polydimethylsiloxyethyl dimethcone, magnesium sulfate, PEG-8 laurate, PEG-9, polyhydroxystearic acid, maltodextrin, benzoic acid, iron oxides, propylene glycol, propylene carbonate, caprylyl glycol, disteardimonim hectorite, cassia alata leaf extract, alumina, aluminum hydroxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-5226 1-888-LRP LABO

Monday - Friday (9 a.m. - 5 p.m. EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69625-899-01La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Sunscreen Broad Spectrum SPF 501 in 1 CARTONLOTION110
69625-899-01La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Sunscreen Broad Spectrum SPF 5050 mL in 1 BOTTLE, PLASTICLOTION5010
69625-899-02La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Sunscreen Broad Spectrum SPF 501 in 1 CARTONLOTION110
69625-899-02La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Sunscreen Broad Spectrum SPF 503 mL in 1 TUBELOTION310

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69625-899LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 TINTED MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 (TITANIUM DIOXIDE) LOTION [COSMETIQUE ACTIVE PRODUCTION]10Current NDC, Legacy NDC, 4 package rows20240116_fd2541e1-c409-40a8-9e3f-6ff69084ea66.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69625-89969625-899-01, 69625-899-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT

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
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDECosmetique Active Productionfd2541e1-c409-40a8-9e3f-6ff69084ea662024-01-15WarningsExact identifier
ndc (package): 69625-899-01
ndc (package): 69625-899-02
ndc (product): 69625-899
ndc11 (package): 69625089901
ndc11 (package): 69625089902
spl id: 7b757c3c-a037-491c-99a0-b9c60d31d452
spl set id: fd2541e1-c409-40a8-9e3f-6ff69084ea66

Reported adverse events (FAERS/openFDA)#

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