LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 MINERAL ULTRA LIGHT SUNSCREEN FACE BROAD SPECTRUM SPF 50- titanium dioxide and zinc oxide lotion 
Cosmetique Active Production

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Drug Facts

Active ingredients

Titanium Dioxide 6%

Zinc Oxide 5%

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

- 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 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, dimethicone, isododecane, C12-15 alkyl benzoate, undecane, triethylhexanoin, isohexadecane, nylon-12, caprylyl methicone, butyloctyl salicylate, phenethyl benzoate, styrene/acrylates copolymer, 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, propylene glycol, caprylyl glycol, PEG-8 laurate, disteardimonium hectorite, triethoxycaprylylsilane diethylhexyl syringylidenemalonate, tocopherol, propylene carbonate, cassia alata leaf extract, maltodextrin, benzoic acid, PEG-9

Questions or comments?

1-888-LRP LABO 1-888-577-5226

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

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LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 MINERAL ULTRA LIGHT SUNSCREEN FACE BROAD SPECTRUM SPF 50 
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69625-907
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide60 mg  in 1 mL
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
UNDECANE (UNII: JV0QT00NUE)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
NYLON-12 (UNII: 446U8J075B)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
PHENETHYL BENZOATE (UNII: 0C143929GK)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
POLYETHYLENE GLYCOL 450 (UNII: 5IRA46LB71)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69625-907-011 in 1 CARTON07/01/201107/01/2011
150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:69625-907-021 in 1 CARTON07/01/201107/01/2011
23 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:69625-907-031 in 1 CARTON12/02/201912/02/2019
35 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02007/01/201112/02/2019
Labeler - Cosmetique Active Production (282658798)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetique Active Production282658798manufacture(69625-907) , pack(69625-907)
Establishment
NameAddressID/FEIBusiness Operations
Interspray364829903pack(69625-907)

Revised: 1/2024
 
Cosmetique Active Production