VICHY LABORATOIRES CAPITAL SOLEIL 60 MINERAL SUNSCREEN BROAD SPECTRUM SPF 60 WATER RESISTANT 80 MINUTES SHEER TINT ULTRA LIGHTWEIGHT- titanium dioxide lotion 
L’Oreal USA Products Inc

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Drug Facts

Active ingredients

Titanium dioxide 14.8%

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:

●  apply liberally 15 minutes before sun exposure

●  reapply:

    ●  after 80 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

Inactive ingredients

water, isododecane, dimethicone, c12-15 alkyl benzoate, undecane, styrene/acrylates copolymer, caprylyl methicone, nylon-12, butyloctyl salicylate, phenethyl benzoate, dicaprylyl carbonate, silica, triethylhexanoin, isohexadecane, tridecane, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum hydroxide, stearic acid, PEG-9 polydimethylsiloxyethyl dimethicone, pentylene glycol, alumina, aluminum stearate, benzoic acid, benzyl benzoate, caprylyl glycol, iron oxides, dipropylene glycol, disodium stearoyl glutamate, disteardimonium hectorite, helianthus annuus seed oil/sunflower seed oil, magnesium sulfate, PEG-8 laurate, phenoxyethanol, polyhydroxystearic acid, propylene carbonate, sodium citrate, sodium dodecylbenzenesulfonate, tocopherol

Questions or comments?

Call toll free 1-877-378-4249

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

image of a carton

image of a carton
VICHY LABORATOIRES CAPITAL SOLEIL 60 MINERAL SUNSCREEN BROAD SPECTRUM SPF 60 WATER RESISTANT 80 MINUTES SHEER TINT ULTRA LIGHTWEIGHT 
titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-650
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE148 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISODODECANE (UNII: A8289P68Y2)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
UNDECANE (UNII: JV0QT00NUE)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
NYLON-12 (UNII: 446U8J075B)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
PHENETHYL BENZOATE (UNII: 0C143929GK)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
TRIDECANE (UNII: A3LZF0L939)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
TALC (UNII: 7SEV7J4R1U)  
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BENZYL BENZOATE (UNII: N863NB338G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-650-011 in 1 CARTON12/01/2019
145 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/01/2019
Labeler - L’Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetique Active Production282658798manufacture(49967-650) , pack(49967-650)

Revised: 12/2023
Document Id: 469e72ca-e993-4577-a804-0d5496fc9d95
Set id: 4692b146-1abe-48e8-b097-ea9c556962b6
Version: 3
Effective Time: 20231211
 
L’Oreal USA Products Inc