Drug Facts

Manufacturer
L'Oreal USA Products Inc | Goodier Cosmetics LP
Effective date
2018-12-26
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 00:12:09

Label at a glance#

ProductLa RochePosay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Sunscreen
Active ingredientTitanium dioxide
Label structure9 sections

Indications and uses

helps prevent sunburn higher SPF gives more sunburn protection retains SPF after 40 minutes of activity in the water or perspiring

Dosage and administration

shake well before use apply evenly before sun exposure reapply as needed or after towel drying, swimming, or perspiring children under 6 months of age: ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 11%

Warnings

WARNINGS SECTION

For external use only

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 or irritation develops and lasts

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

  • shake well before use
  • apply evenly before sun exposure
  • reapply as needed or after towel drying, swimming, or perspiring
  • children under 6 months of age: ask a doctor

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 dimethicone, alumina, polyhydroxystearic acid, phenoxyethanol, magnesium sulfate, protpylene glycol, caprylyl glycol, aluminum hydroxide, PEG-8 laurate, stearic acid, disteardimonium hectorite, diethylhexyl syringylidenemalonate, tocopherol, propylene carbonate, cassia alata leaf extract, maltodextrin, benzoic acid, PEG-9

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • retains SPF after 40 minutes of activity in the water or perspiring

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a labelimage of a label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium dioxideACTIVE INGREDIENT15FIX9V2JP4
Titanium dioxideACTIVE MOIETY15FIX9V2JP4

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-09049967-090-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 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
68cd7375-9821-400e-9121-c789569d1cb052d494ac-59dd-405d-9d78-5c768de01c392018-12-26WarningsExact identifier
spl id: 68cd7375-9821-400e-9121-c789569d1cb0
spl set id: 52d494ac-59dd-405d-9d78-5c768de01c39

Reported adverse events (FAERS/openFDA)#

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