VICHY LABORATOIRES CAPITAL SOLEIL 60 MINERAL SUNSCREEN BROAD SPECTRUM SPF 60 WATER RESISTANT 80 MINUTES SHEER TINT ULTRA LIGHTWEIGHT- titanium dioxide lotion

Vichy Laboratoires Capital Soleil 60 Mineral Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra Lightweight by

Drug Labeling and Warnings

Vichy Laboratoires Capital Soleil 60 Mineral Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra Lightweight by is a Otc medication manufactured, distributed, or labeled by L’Oreal USA Products Inc, Cosmetique Active Production. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium dioxide 14.8%

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

For sunscreen use:

• shake well before 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

• protect the product in this container from excessive heat and direct sun
• store at 68 – 77° F (20 – 25°C)

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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-650
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	148 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-650-01	1 in 1 CARTON	12/01/2019
1		45 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 Drug	M020	12/01/2019

Labeler - L’Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetique Active Production		282658798	manufacture(49967-650) , pack(49967-650)