OTC Medication Information: La Roche Posay Laboratoire Dermatologique Anthelios HA Mineral Broad Spectrum SPF 30 Daily Moisturizing Sunscreen

LA 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

Active ingredients

Titanium dioxide 5.5%

Zinc oxide 10%

Purpose

Sunscreen

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

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

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

Inactive ingredients

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?

1-888-LRP-LAB0 1-888-577-5226

Monday — Friday (9 a.m. — 5 p.m. EST)

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LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS HA MINERAL BROAD SPECTRUM SPF 30 DAILY MOISTURIZING SUNSCREEN
titanium dioxide and zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-460
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 55 mg in 1 mL
ZINC OXIDE (ZINC CATION) ZINC CATION 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
ISOHEXADECANE
ISONONYL ISONONANOATE
DICAPRYLYL ETHER
PEG-30 DIPOLYHYDROXYSTEARATE
ALKYL (C12-15) BENZOATE
POLYGLYCERYL-4 ISOSTEARATE
DIMETHICONE
CAPRYLYL TRISILOXANE
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S)
MEDIUM-CHAIN TRIGLYCERIDES
TRIETHYLHEXANOIN
SILICON DIOXIDE
CITRIC ACID MONOHYDRATE
PHENOXYETHANOL
SODIUM CHLORIDE
CAPRYLYL GLYCOL
PANTHENOL
DIETHYLHEXYL SYRINGYLIDENEMALONATE
ALUMINUM HYDROXIDE
STEARIC ACID
ALUMINUM STEARATE
HYALURONATE SODIUM
TRIETHOXYCAPRYLYLSILANE
CHLORPHENESIN
DISTEARDIMONIUM HECTORITE
ALUMINUM OXIDE
POLYHYDROXYSTEARIC ACID (2300 MW)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE
TOCOPHEROL
P-ANISIC ACID
CAPRYLOYL SALICYLIC ACID
XANTHAN GUM
PROPYLENE CARBONATE
SENNA ALATA LEAF
MALTODEXTRIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49967-460-01 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 mL in 1 BOTTLE This package is contained within the CARTON (49967-460-01)
2 NDC:49967-460-02 1 TUBE in 1 CARTON contains a TUBE
2 5 mL in 1 TUBE This package is contained within the CARTON (49967-460-02)
3 NDC:49967-460-03 2 mL in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 12/01/2020
Labeler — L’Oreal USA Products Inc (002136794)
Establishment
Name Address ID/FEI Operations
L’Oreal USA, INC. 185931458 manufacture (49967-460)

Revised: 01/2024 L’Oreal USA Products Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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