FDA.reportPublic FDA data

Drug Facts

Manufacturer
L'Oreal USA Products Inc | Goodier Cosmetics
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:20

Label at a glance#

ProductLa Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Daily Tone Correcting Primer Broad Spectrum SPF 50 Sun...
Active ingredientTITANIUM DIOXIDE
Label structure13 sections

Indications and uses

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

Dosage and administration

For sunscreen 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 of higher and other sun protection measures including: limit time in t...

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 25%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed (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 tjhis 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:

  • 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 of 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

dimethicone, C12-15 alkyl benzoate, dicaprylyl ether, dimethicone/vinyl dimethicone crosspolymer, talc, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, hydrogenated jojoba oil, aluminum hydroxide, stearic acid, aluminum stearate, iron oxides, silica silylate, alumina, polyhydroxystearic acid, PEG-8 lasurate, tocopherol, water, diethylhexyl syringylidenemalonate, laureth-4, disodium stearoyl glutamate, cassia alata leaf extract, maltodextrin, caprylic/capric triglyceride

Questions or comments?

OTC - QUESTIONS SECTION

1-888-LRP-LABO  1-888-577-5226

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-525-01La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Daily Tone Correcting Primer Broad Spectrum SPF 50 Sunscreen1 in 1 CARTONLOTION12
49967-525-01La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Daily Tone Correcting Primer Broad Spectrum SPF 50 Sunscreen40 mL in 1 TUBELOTION402
49967-525-02La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Daily Tone Correcting Primer Broad Spectrum SPF 50 Sunscreen2 mL in 1 PACKETLOTION22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-525LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 MINERAL DAILY TONE CORRECTING PRIMER BROAD SPECTRUM SPF 50 SUNSCREEN (TITANIUM DIOXIDE) LOTION [L'OREAL USA PRODUCTS INC]2Current NDC, Legacy NDC, 3 package rows20240102_89b59bd7-9a91-4b99-84e7-996a8b1d499e.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-52549967-525-01, 49967-525-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
DIMETHICONE92RU3N3Y1OIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DICAPRYLYL ETHER77JZM5516ZIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)H895X08VNQIACT
TALC7SEV7J4R1UIACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
ISOHEXADECANE918X1OUF1EIACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
HYDROGENATED JOJOBA OIL7F674YQ5SOIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
ALUMINUM STEARATEU6XF9NP8HMIACT
FERRIC OXIDE RED1K09F3G675IACT
ALUMINUM OXIDELMI26O6933IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PEG-8 LAURATE762O8IWA10IACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
LAURETH-46HQ855798JIACT
DISODIUM STEAROYL GLUTAMATE45ASM2L11MIACT
SENNA ALATA LEAF4BXR6YZN92IACT
MALTODEXTRIN7CVR7L4A2DIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT

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 Mineral Daily Tone Correcting Primer Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc89b59bd7-9a91-4b99-84e7-996a8b1d499e2024-01-01WarningsExact identifier
ndc (package): 49967-525-02
ndc (package): 49967-525-01
ndc (product): 49967-525
ndc11 (package): 49967052501
ndc11 (package): 49967052502
spl id: f1c47f56-d5f5-4eed-8e62-a2aaa579cd02
spl set id: 89b59bd7-9a91-4b99-84e7-996a8b1d499e

Reported adverse events (FAERS/openFDA)#

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