LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS HA MINERAL BROAD SPECTRUM SPF 30 DAILY MOISTURIZING SUNSCREEN- titanium dioxide and zinc oxide cream

La Roche Posay Laboratoire Dermatologique Anthelios HA Mineral Broad Spectrum SPF 30 Daily Moisturizing Sunscreen by

Drug Labeling and Warnings

La Roche Posay Laboratoire Dermatologique Anthelios HA Mineral Broad Spectrum SPF 30 Daily Moisturizing Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'Oreal USA, INC., Unette Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	55 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PANTHENOL (UNII: WV9CM0O67Z)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
TOCOPHEROL (UNII: R0ZB2556P8)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SENNA ALATA LEAF (UNII: 4BXR6YZN92)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-460-01	1 in 1 CARTON	12/01/2020
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49967-460-02	1 in 1 CARTON	12/01/2020
2		5 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 49967-460-03	2 mL in 1 PACKET; Type 0: Not a Combination Product	12/01/2020

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	Business Operations
L'Oreal USA, INC.		185931458	manufacture(49967-460)