LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 MINERAL DAILY TONE CORRECTING PRIMER BROAD SPECTRUM SPF 50 SUNSCREEN- titanium dioxide lotion

La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Daily Tone Correcting Primer Broad Spectrum SPF 50 Sunscreen by

Drug Labeling and Warnings

La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Daily Tone Correcting Primer Broad Spectrum SPF 50 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Goodier Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Titanium dioxide 25%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed (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 tjhis 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 if swimming or sweating
• 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 of 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

dimethicone, C12-15 alkyl benzoate, dicaprylyl ether, dimethicone/vinyl dimethicone crosspolymer, talc, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, hydrogenated jojoba oil, aluminum hydroxide, stearic acid, aluminum stearate, iron oxides, silica silylate, alumina, polyhydroxystearic acid, PEG-8 lasurate, tocopherol, water, diethylhexyl syringylidenemalonate, laureth-4, disodium stearoyl glutamate, cassia alata leaf extract, maltodextrin, caprylic/capric triglyceride

Questions or comments?

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 MINERAL DAILY TONE CORRECTING PRIMER BROAD SPECTRUM SPF 50 SUNSCREEN 
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-525
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	250 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
TALC (UNII: 7SEV7J4R1U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
ISOHEXADECANE (UNII: 918X1OUF1E)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PEG-8 LAURATE (UNII: 762O8IWA10)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
LAURETH-4 (UNII: 6HQ855798J)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
SENNA ALATA LEAF (UNII: 4BXR6YZN92)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-525-01	1 in 1 CARTON	01/01/2016
1		40 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-525-02	2 mL in 1 PACKET; Type 0: Not a Combination Product	01/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2016

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Goodier Cosmetics LP		007317209	manufacture(49967-525)