La RochePosay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Sunscreen by L'Oreal USA Products Inc / Goodier Cosmetics LP Drug Facts

Drug Details [pdf]

LA ROCHEPOSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 MINERAL ULTRA LIGHT 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%

Warnings

For external use only

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash or irritation develops and lasts

Keep out of reach of children.

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

Directions

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

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

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

image of a label

LA ROCHEPOSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 MINERAL ULTRA LIGHT SUNSCREEN
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-090
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	110 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
UNDECANE (UNII: JV0QT00NUE)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
ISOHEXADECANE (UNII: 918X1OUF1E)
NYLON-12 (UNII: 446U8J075B)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENETHYL BENZOATE (UNII: 0C143929GK)
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)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 49967-090-01	1 in 1 CARTON	07/01/2011	11/28/2014
1		50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/01/2011	11/28/2014

Labeler - L'Oreal USA Products Inc (002136794)

Name	Address	ID/FEI	Business Operations
Establishment
Goodier Cosmetics LP		007317209	manufacture(49967-090)

Revised: 1/2020

Document Id: 8ca251a5-31cc-4ae6-a607-c29f936b67ac

Set id: 52d494ac-59dd-405d-9d78-5c768de01c39

Version: 6

Effective Time: 20200117

L'Oreal USA Products Inc