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Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'OREAL USA, INC.
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-06-01 00:06:21

Label at a glance#

ProductLa Roche Posay New 50 Body and Face SPF 50 Mineral Anthelios Gentle 100 percent mineral UV filters Soft finish with C...
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 cuased by the sun

Dosage and administration

For sunscreen use: apply generously 15 minutes before sun exposure reapply:    after 80 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 measures...

Storage and handling

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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 5%

Zinc Oxide 15%

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 cuased 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:
  •    after 80 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 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 is this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, C12-15 alkyl benzoate, isohexadecane, isononyl isononanoate, dicaprylyl ether, PEG-30 dipolyhydroxystearate, polyglyceryl-4 isostearate, dicaprylyl carbonate, ethylene/acrylic acid copolymer, triethylhexanoin, silica, poly C10-30 alkyl acrylate, citric acid, phenoxyethanol, sodium chloride, caprylyl glycol, diethylhexyl syringylidenemalonate, triethoxycaprylylsilane, aluminum hydroxide, stearic acid, aluminum stearate, chlorphnesin, disteardimonium hectorite, alumina, polyhydroxystearic acid, tocopherol, p-ansic acid, capryloyl salicylic acid, xanthan gum, disodium EDTA, propylene carbonate, caprylic/capric triglyceride, cassia alata leaf extract, maltodextrin

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

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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
49967-091-01La Roche Posay New 50 Body and Face SPF 50 Mineral Anthelios Gentle 100 percent mineral UV filters Soft finish with Cell Ox Shield120 mL in 1 TUBELOTION12015
49967-091-02La Roche Posay New 50 Body and Face SPF 50 Mineral Anthelios Gentle 100 percent mineral UV filters Soft finish with Cell Ox Shield90 mL in 1 TUBELOTION9015
49967-091-03La Roche Posay New 50 Body and Face SPF 50 Mineral Anthelios Gentle 100 percent mineral UV filters Soft finish with Cell Ox Shield5 mL in 1 PACKETLOTION515
49967-091-04La Roche Posay New 50 Body and Face SPF 50 Mineral Anthelios Gentle 100 percent mineral UV filters Soft finish with Cell Ox Shield5 mL in 1 TUBELOTION515
49967-091-05La Roche Posay New 50 Body and Face SPF 50 Mineral Anthelios Gentle 100 percent mineral UV filters Soft finish with Cell Ox Shield150 mL in 1 TUBELOTION15015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-091LA ROCHE POSAY NEW 50 BODY AND FACE SPF 50 MINERAL ANTHELIOS GENTLE 100 PERCENT MINERAL UV FILTERS SOFT FINISH WITH CELL OX SHIELD (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]15Current NDC, Legacy NDC, 5 package rows20240102_c0f7ae46-7161-4d48-9386-007bfafecfd5.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-09149967-091-01, 49967-091-02, 49967-091-03, 49967-091-04, 49967-091-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ISOHEXADECANE918X1OUF1EIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
DICAPRYLYL ETHER77JZM5516ZIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM CHLORIDE451W47IQ8XIACT
CAPRYLYL GLYCOL00YIU5438UIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
ALUMINUM STEARATEU6XF9NP8HMIACT
CHLORPHENESINI670DAL4SZIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ALUMINUM OXIDELMI26O6933IACT
TOCOPHEROLR0ZB2556P8IACT
P-ANISIC ACID4SB6Y7DMM3IACT
CAPRYLOYL SALICYLIC ACID5F7PJF6AA4IACT
XANTHAN GUMTTV12P4NEEIACT
EDETATE DISODIUM7FLD91C86KIACT
PROPYLENE CARBONATE8D08K3S51EIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SENNA ALATA LEAF4BXR6YZN92IACT
MALTODEXTRIN7CVR7L4A2DIACT

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 New 50 Body and Face SPF 50 Mineral Anthelios Gentle 100 percent mineral UV filters Soft finish with Cell Ox ShieldTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Incc0f7ae46-7161-4d48-9386-007bfafecfd52024-01-01WarningsExact identifier
ndc (package): 49967-091-01
ndc (package): 49967-091-03
ndc (package): 49967-091-05
ndc (package): 49967-091-04
ndc (package): 49967-091-02
ndc (product): 49967-091
ndc11 (package): 49967009104
ndc11 (package): 49967009101
ndc11 (package): 49967009105
ndc11 (package): 49967009102
ndc11 (package): 49967009103
spl id: 5e3f83d1-03e6-4aff-b18c-5286ee1da034
spl set id: c0f7ae46-7161-4d48-9386-007bfafecfd5

Reported adverse events (FAERS/openFDA)#

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