NDC Code(s) : 67015-0789-1, 67015-0789-5
Packager : Pierre Fabre Dermo-Cosmetique USA, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Eau Thermale Avene Ultra-Light Hydrating Sunscreen SPF 50Avobenzone, Homosalate, Octisalate, Octocrylene SPRAY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67015-0789
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE30 mg in 1 g
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE130 mg in 1 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE50 mg in 1 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE100 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
ISONONYL ISONONANOATE(UNII: S4V5BS6GCX)
ISODODECANE(UNII: A8289P68Y2)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
ISOHEXADECANE(UNII: 918X1OUF1E)
DIMETHICONE(UNII: 92RU3N3Y1O)
POLYESTER-7(UNII: 0841698D2F)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)(UNII: T9296U138P)
NEOPENTYL GLYCOL DIHEPTANOATE(UNII: 5LKW3C543X)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
ETHYLHEXYL METHOXYCRYLENE(UNII: S3KFG6Q5X8)
SORBITOL(UNII: 506T60A25R)
ARACHIDYL GLUCOSIDE(UNII: 6JVW35JOOJ)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ARACHIDYL ALCOHOL(UNII: 1QR1QRA9BU)
DOCOSANOL(UNII: 9G1OE216XY)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
STEARETH-2(UNII: V56DFE46J5)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER(UNII: V5RS026Q0H)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
XANTHAN GUM(UNII: TTV12P4NEE)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
POLYGLYCERYL-3 DISTEARATE(UNII: ZI1LK470XV)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
OLEIC ACID(UNII: 2UMI9U37CP)
EDETATE DISODIUM(UNII: 7FLD91C86K)
STEARETH-100(UNII: 4OH5W9UM87)
YEAST MANNAN(UNII: 91R887N59P)
P-ANISIC ACID(UNII: 4SB6Y7DMM3)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67015-0789-128 g in 1 BOTTLE, SPRAY Type 0: Not a Combination Product
2NDC:67015-0789-5141.7 g in 1 BOTTLE, SPRAY Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part352 03/06/2015

PRINCIPAL DISPLAY PANEL

Eau Thermale Avene Ultra-Light Hydrating Sunscreen Lotion Spray SPF 50+

Eau Thermale Avene Ultra-Light Hydrating Sunscreen Lotion Spray SPF 50+