VICHY LABORATOIRES CAPITAL SOLEIL 50 DAILY ANTIAGING FACE SUNSCREEN BROAD SPECTRUM SPF 50 WATER RESISTANT 80 MINUTES- avobenzone, homosalate, octisalate and octocrylene lotion

Vichy Laboratoires Capital Soleil 50 Daily AntiAging Face Sunscreen Broad Spectrum SPF 50 Water Resistant 80 Minutes by

Drug Labeling and Warnings

Vichy Laboratoires Capital Soleil 50 Daily AntiAging Face Sunscreen Broad Spectrum SPF 50 Water Resistant 80 Minutes by is a Otc medication manufactured, distributed, or labeled by L’Oreal USA Products Inc, L’Oreal USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

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

Flammable until dry.

Keep away from flames and heat.

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

protect the product in this container from excessive heat and direct sun

Inactive ingredients

water, cyclopentasiloxane, alcohol denat., silica, dicaprylyl ether, styrene/acrylates copolymer, PEG-30 dipolyhydroxystearate, dimethicone, cyclohexasiloxane, polymethylsilsesquioxane, glycerin, nylon-12, butylene glycol, caprylyl glycol, citric acid, dicaprylyl carbonate, disodium EDTA, disteardimonium hectorite, fragrance, isostearyl alcohol, lauryl PEG/PPG-18/18 methicone, p-anisic acid, PEG-8 laurate, phenoxyethanol, poly c10-30 alkyl acrylate, potassium sorbate, propylene carbonate, sodium benzoate, sodium chloride, sodium dodecylbenzenesulfonate, tocopherol,
vitis vinifera (grape) fruit extract

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 50 DAILY ANTIAGING FACE SUNSCREEN BROAD SPECTRUM SPF 50 WATER RESISTANT 80 MINUTES 
avobenzone, homosalate, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-054
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALCOHOL (UNII: 3K9958V90M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
NYLON-12 (UNII: 446U8J075B)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
PEG-8 LAURATE (UNII: 762O8IWA10)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
TOCOPHEROL (UNII: R0ZB2556P8)
WINE GRAPE (UNII: 3GOV20705G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-054-01	1 in 1 CARTON	05/01/2020
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49967-054-02	1 in 1 CARTON	05/01/2020	05/01/2020
2		50 mL in 1 TUBE; 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	05/01/2020

Labeler - L’Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L’Oreal USA, Inc.		185931458	analysis(49967-054)

Establishment
Name	Address	ID/FEI	Business Operations
Goodier Cosmetics		007317209	manufacture(49967-054)