Vichy Laboratoires Capital Soleil SPF 50 Ultra Light Sunscreen by L'Oreal USA Products Inc / Goodier Cosmetics LP Drug Facts

Drug Details [pdf]

VICHY LABORATOIRES CAPITAL SOLEIL SPF 50 ULTRA LIGHT SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene and oxybenzone 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 ingredients

Avobenzone 3%; Homosalate 10%; Octisalate 5%; Octocrylene 5%; Oxybenzone 6%

Warnings

For external use only

Whenn 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 liberally on face and body 15 minutes before sun exposure
reapply after 40 minutes of swimming or perspiring and after towel drying
children under 6 months of age: ask a doctor

Inactive ingredients

water, cyclopentasiloxane, alcohol denat., silica, dicaprylyl ether, styrene/acrylates copolymer, PEG-30 dipolyhydroxystearate, dimethicone, cyclohexasiloxane, polymethylsilsesquioxane, nylon-12, dicaprylyl carbonate, phenoxyethanol, lauryl PEG/PPG-18/18 methicone, sodium chloride, caprylyl glycol, PEG-8 laurate, methylparaben, poly C10-30 alkyl acrylate, disteardimonium hectorite, isostearyl alcohol, disodium EDTA, dodecene, poloxamer 407, tocopherol, vitis vinifera (grape) fruit extract

Uses

helps prevent sunburn
higher SPF gives more sunburn protection
retains SPF after 40 minutes of activity in the water or perspiring
provides protection from the UVA rays that may contribute to skin damage and premature aging of the skin

image of a label

VICHY LABORATOIRES CAPITAL SOLEIL SPF 50 ULTRA LIGHT SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-891
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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	50 mg in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	60 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
DIMETHICONE (UNII: 92RU3N3Y1O)
NYLON-12 (UNII: 446U8J075B)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG-8 LAURATE (UNII: 762O8IWA10)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DODECENE (UNII: WYE669F3GR)
POLOXAMER 407 (UNII: TUF2IVW3M2)
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 49967-891-01	1 in 1 CARTON	07/01/2011	01/30/2015
1		50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/01/2011	01/30/2015

Labeler - L'Oreal USA Products Inc (002136794)

Name	Address	ID/FEI	Business Operations
Establishment
Goodier Cosmetics LP		007317209	manufacture(49967-891)

Revised: 1/2020

Document Id: 71848a35-fb42-4c3f-a28a-33042b6bc68a

Set id: ba323a50-0e8c-408f-b8ba-3a3696b4b7c0

Version: 5

Effective Time: 20200117

L'Oreal USA Products Inc