Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'Oreal USA, INC.
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:06:19

Label at a glance#

ProductLa Roche Posay Laboratoire Dermatologique Anthelios HA Mineral Broad Spectrum SPF 30 Daily Moisturizing Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
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: ● apply generously 15 minutes before sun exposure ● reapply at least every 2 hours ● use a water resistant sunscreen after 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 ...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 5.5%

Zinc oxide 10%

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:

● apply generously 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen after 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 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

water, glycerin, isohexadecane, isononyl isononanoate, dicaprylyl ether, PEG-30 dipolyhydroxystearate, c12-15 alkyl benzoate, polyglyceryl-4 isostearate, dimethicone, caprylyl methicone, ethylene/acrylic acid copolymer, caprylic/capric triglyceride, triethylhexanoin, silica, poly c10-30 alkyl acrylate, citric acid, phenoxyethanol, sodium chloride, caprylyl glycol, panthenol, diethylhexyl syringylidenemalonate, aluminum hydroxide, stearic acid, aluminum stearate, sodium hyaluronate, triethoxycaprylylsilane, chlorphenesin, disteardimonium hectorite, alumina, polyhydroxystearic acid, trisodium ethylenediamine disuccinate, tocopherol, p-anisic acid, capryloyl salicylic acid, xanthan gum, propylene carbonate, cassia alata leaf extract, maltodextrin

Questions or comments?

OTC - QUESTIONS SECTION

1-888-LRP-LAB0 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

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DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-460-01La Roche Posay Laboratoire Dermatologique Anthelios HA Mineral Broad Spectrum SPF 30 Daily Moisturizing Sunscreen1 in 1 CARTONCREAM110
49967-460-01La Roche Posay Laboratoire Dermatologique Anthelios HA Mineral Broad Spectrum SPF 30 Daily Moisturizing Sunscreen50 mL in 1 BOTTLECREAM5010
49967-460-02La Roche Posay Laboratoire Dermatologique Anthelios HA Mineral Broad Spectrum SPF 30 Daily Moisturizing Sunscreen1 in 1 CARTONCREAM110
49967-460-02La Roche Posay Laboratoire Dermatologique Anthelios HA Mineral Broad Spectrum SPF 30 Daily Moisturizing Sunscreen5 mL in 1 TUBECREAM510
49967-460-03La Roche Posay Laboratoire Dermatologique Anthelios HA Mineral Broad Spectrum SPF 30 Daily Moisturizing Sunscreen2 mL in 1 PACKETCREAM210

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-460LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS HA MINERAL BROAD SPECTRUM SPF 30 DAILY MOISTURIZING SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [L'OREAL USA PRODUCTS INC]10Current NDC, Legacy NDC, 5 package rows20240102_7bca5947-88a3-4cb3-a6f2-9fa389d344ef.zip

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-46049967-460-01, 49967-460-02, 49967-460-03

Ingredients#

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

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

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 HA Mineral Broad Spectrum SPF 30 Daily Moisturizing SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc7bca5947-88a3-4cb3-a6f2-9fa389d344ef2024-01-01WarningsExact identifier
ndc (package): 49967-460-02
ndc (package): 49967-460-01
ndc (package): 49967-460-03
ndc (product): 49967-460
ndc11 (package): 49967046002
ndc11 (package): 49967046003
ndc11 (package): 49967046001
spl id: 62c3812a-687f-4a06-aca0-2ea6908e7445
spl set id: 7bca5947-88a3-4cb3-a6f2-9fa389d344ef

Reported adverse events (FAERS/openFDA)#

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