LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 TINTED MINERAL FACE BROAD SPECTRUM SPF 50 SUNSCREEN- titanium dioxide lotion
L'Oreal USA Products Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Titanium dioxide 11%

Purpose

Sunscreen

Uses

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:

- shake well before use

- apply generously 15 minutes before sun exposure

- reapply:

- after 40 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 meausures 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

Inactive ingredients

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 dimethcone, iron oxides, alumina, polyhydroxystearic acid, phenoxyethanol, magnesium sulfate, propylene glycol, caprylyl glycol, aluminum hydroxide, PEG-8 laurate, stearic acid, disteardimonium hectorite, diethylhexyl syringlidenemalonate, tocopherol, propylene carbonate, cassia alata leaf extract, maltodextrin, benzoic acid, disodium stearoyl glutamate, PEG-9

Questions or comments?

1-888-577-5226   1-888-LRP LABO

Monday - Friday (9 a.m. - 5 p.m. EST)

image of a carton

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 TINTED MINERAL FACE BROAD SPECTRUM SPF 50 SUNSCREEN
titanium dioxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-020
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 110 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
UNDECANE (UNII: JV0QT00NUE)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
ISOHEXADECANE (UNII: 918X1OUF1E)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
NYLON-12 (UNII: 446U8J075B)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENETHYL BENZOATE (UNII: 0C143929GK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIDECANE (UNII: A3LZF0L939)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MAGNESIUM SULFATE (UNII: DE08037SAB)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PEG-8 LAURATE (UNII: 762O8IWA10)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
TOCOPHEROL (UNII: R0ZB2556P8)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SENNA ALATA LEAF (UNII: 4BXR6YZN92)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49967-020-01 1 in 1 CARTON 01/30/2017
1 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2 NDC:49967-020-02 1 in 1 CARTON 01/30/2017
2 3 mL in 1 TUBE; Type 0: Not a Combination Product
3 NDC:49967-020-03 1 in 1 CARTON 01/30/2017
3 125 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/30/2017
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
Name Address ID/FEI Business Operations
Cosmetique Active Production 282658798 manufacture(49967-020) , analysis(49967-020)
Establishment
Name Address ID/FEI Business Operations
Interspray 364829903 pack(49967-020)

Revised: 2/2017
Document Id: 8e6a42a3-9fe3-41b8-b3ed-adafda0f2e16
Set id: bc72048a-4786-44c2-97ce-022082281654
Version: 1
Effective Time: 20170221
L'Oreal USA Products Inc