VICHY LABORATOIRES AQUALIA THERMAL SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene lotion

Vichy Laboratoires Aqualia Thermal Sunscreen by

Drug Labeling and Warnings

Vichy Laboratoires Aqualia Thermal Sunscreen 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

Avobenzone 3%

Homosalate 6%

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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

Directions

For sunscreen use:

● apply liberally 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● 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, isononyl isononanoate, glycerin, dimethicone, diisopropyl sebacate, aluminum starch octenylsuccinate, sucrose tristearate, stryene/acrylates copolymer, polysorbate 61, PEG-12 dimethicone, PEG-8 laurate, carbomer, triethanolamine, dimethiconol, sodium stearoyl glutamate, sodium hyaluronate, phenoxyethanol, tocopheryl acetate, disodium EDTA, caprylyl glycol, biosaccharide gum-1, xanthan gum, fragrance

Questions or comments?

Call toll free 1-877-378-4249

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VICHY LABORATOIRES AQUALIA THERMAL SUNSCREEN 
avobenzone, homosalate, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-041
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	60 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)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
SUCROSE TRISTEARATE (UNII: 71I93STU5M)
POLYSORBATE 61 (UNII: X9E1MY2JQG)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
PEG-8 LAURATE (UNII: 762O8IWA10)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
TROLAMINE (UNII: 9O3K93S3TK)
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-041-01	1 in 1 CARTON	04/01/2013
1		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2013

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetique Active Production		282658798	manufacture(49967-041)