Vichy Laboratoire Capital Soleil SPF 60 Soft Sheer Sunscreen by L'Oreal USA Products Inc Drug Facts

Drug Details [pdf]

VICHY LABORATOIRE CAPITAL SOLEIL SPF 60 SOFT SHEER 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.

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Drug Facts

Active ingredients

Avobenzone 3%; Homosalate 15%; Octisalate 5%; Octocrylene 5%; Oxybenzone 6%

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

Warnings

For external use only

When 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

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

Inactive ingredients

water, silica, styrene/acrylates copolymer, butyloctyl salicylate, glycerin, poly C10-30 alkyl acrylate, PEG-100 stearate, glyceryl stearate, caprylyl methicone, trisiloxane, dicaprylyl carbonate, phenoxyethanol, potassium cetayl phosphate, dimethicone, caprylyl glycol, PEG-8 laurate, cyclopentasiloxane, methylparaben, inulin lauryl carbamate, chlorphenesin, triethanolamine, ethylparaben, acrylates/C10-30 alkyl acrylate crosspolyer,xanthan gum, disodium EDTA, dimethicone crosspolymer, tocopherol, vitis vinfera (grape) fruit extract

image of a label

VICHY LABORATOIRE CAPITAL SOLEIL SPF 60 SOFT SHEER SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-088
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	150 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)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-100 STEARATE (UNII: YD01N1999R)
TRISILOXANE (UNII: 9G1ZW13R0G)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG-8 LAURATE (UNII: 762O8IWA10)
METHYLPARABEN (UNII: A2I8C7HI9T)
CHLORPHENESIN (UNII: I670DAL4SZ)
ETHYLPARABEN (UNII: 14255EXE39)
XANTHAN GUM (UNII: TTV12P4NEE)
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 49967-088-01	1 in 1 CARTON	04/21/2011	04/17/2017
1		150 mL in 1 TUBE; 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	04/21/2011	04/17/2017

Labeler - L'Oreal USA Products Inc (002136794)

Name	Address	ID/FEI	Business Operations
Establishment
L'Oreal USA Products Inc		185931458	manufacture(49967-088)

Revised: 1/2020

Document Id: bbeca870-8181-4f70-9069-4c891c9a26c3

Set id: ceba2135-db36-46ec-ae81-f4a86c038221

Version: 3

Effective Time: 20200117

L'Oreal USA Products Inc