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Drug Facts

Manufacturer
Cosmetique Active Production | Interspray
Effective date
2023-12-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:04:13

Label at a glance#

ProductLa Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 Sunscreen
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 othe...

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, PEG-9 polydimethylsiloxyethyl dimethcone, iron oxides, alumina, polyhydroxystearic acid, phenoxyethanol, magnesium sulfate, propylene glycol, caprylyl glycol, aluminum hydroxide, PEG-8 laurate, stearic acid, disteardimonium hectorite, diethylhexyl syringlidenemalonate, tocopherol, propylene carbonate, cassia alata leaf extract, maltodextrin, benzoic acid, disodium stearoyl glutamate, PEG-9

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 of a cartonimage of a carton

image of a carton
image of a carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69625-019-01La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 Sunscreen1 in 1 CARTONLOTION11
69625-019-01La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 Sunscreen50 mL in 1 BOTTLE, PLASTICLOTION501
69625-019-02La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 Sunscreen5 mL in 1 TUBELOTION51
69625-019-02La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 Sunscreen1 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69625-019LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 TINTED MINERAL FACE BROAD SPECTRUM SPF 50 SUNSCREEN (TITANIUM DIOXIDE) LOTION [COSMETIQUE ACTIVE PRODUCTION]1Current NDC, 4 package rows20231214_4d5d1e79-7b3e-41b5-ae6b-a3b0265702ca.zip

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69625-01969625-019-01, 69625-019-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
WATER059QF0KO0RIACT
ISODODECANEA8289P68Y2IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DIMETHICONE92RU3N3Y1OIACT
UNDECANEJV0QT00NUEIACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
ISOHEXADECANE918X1OUF1EIACT
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)5Z4DPO246AIACT
NYLON-12446U8J075BIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
PHENETHYL BENZOATE0C143929GKIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TRIDECANEA3LZF0L939IACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
DICAPRYLYL ETHER77JZM5516ZIACT
TALC7SEV7J4R1UIACT
ALUMINUM STEARATEU6XF9NP8HMIACT
PENTYLENE GLYCOL50C1307PZGIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
FERRIC OXIDE RED1K09F3G675IACT
ALUMINUM OXIDELMI26O6933IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
PEG-8 LAURATE762O8IWA10IACT
STEARIC ACID4ELV7Z65APIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
TOCOPHEROLR0ZB2556P8IACT
PROPYLENE CARBONATE8D08K3S51EIACT
SENNA ALATA LEAF4BXR6YZN92IACT
MALTODEXTRIN7CVR7L4A2DIACT
BENZOIC ACID8SKN0B0MIMIACT
DISODIUM STEAROYL GLUTAMATE45ASM2L11MIACT

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
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDECosmetique Active Production4d5d1e79-7b3e-41b5-ae6b-a3b0265702ca2023-12-13WarningsExact identifier
ndc (package): 69625-019-02
ndc (package): 69625-019-01
ndc (product): 69625-019
ndc11 (package): 69625001902
ndc11 (package): 69625001901
spl id: c41bcab3-9d2a-451f-a678-8fbb37a53161
spl set id: 4d5d1e79-7b3e-41b5-ae6b-a3b0265702ca

Reported adverse events (FAERS/openFDA)#

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