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

La RochePosay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Sunscreen by

Drug Labeling and Warnings

La RochePosay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Goodier Cosmetics LP. Drug facts, warnings, and ingredients follow.

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.

----------

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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 49967-090
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide110 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49967-090-011 in 1 CARTON07/01/201111/28/2014
150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/01/201111/28/2014
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Goodier Cosmetics LP007317209manufacture(49967-090)

Revised: 1/2020
 
L'Oreal USA Products Inc