NDC Code(s) : 58668-0961-1
Packager : Laboratoires Clarins S.A.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CLARINS Super Restorative Day Illuminating lifting replenishing BROAD SPECTRUM - SPF 20 - SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58668-0961
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 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE100 mg in 1 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE27 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE(UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
ALCOHOL(UNII: 3K9958V90M)
DIMETHICONE(UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
SHEA BUTTER(UNII: K49155WL9Y)
POTASSIUM CETYL PHOSPHATE(UNII: 03KCY6P7UT)
TROMETHAMINE(UNII: 023C2WHX2V)
CETEARYL GLUCOSIDE(UNII: 09FUA47KNA)
ASCORBYL GLUCOSIDE(UNII: 2V52R0NHXW)
SUCROSE PALMITATE(UNII: 3OSQ643ZK5)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
XANTHAN GUM(UNII: TTV12P4NEE)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERYL MONOLINOLEATE(UNII: 4763AXI84L)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
EDETATE DISODIUM(UNII: 7FLD91C86K)
CANDELILLA WAX(UNII: WL0328HX19)
TOCOPHEROL(UNII: R0ZB2556P8)
MICA(UNII: V8A1AW0880)
BARIUM SULFATE(UNII: 25BB7EKE2E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
PROPANEDIOL(UNII: 5965N8W85T)
BLACK OLIVE(UNII: 2M6QWV94OC)
PECTIN(UNII: 89NA02M4RX)
THERMUS THERMOPHILUS LYSATE(UNII: 775R692494)
SUNFLOWER OIL(UNII: 3W1JG795YI)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
LAPSANA COMMUNIS FLOWERING TOP(UNII: T9B77O7PZA)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
SEDUM ROSEUM ROOT(UNII: 3S5ITS5ULN)
FD&C RED NO. 4(UNII: X3W0AM1JLX)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58668-0961-11 in 1 CARTON 29/07/2013
150 mL in 1 JAR 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 07/29/2013

LABELER - Laboratoires Clarins S.A.(266317555)

Establishment
Name Address ID/FEI Business Operations
Laboratoires Clarins S.A. 266317555 manufacture(58668-0961)

PRINCIPAL DISPLAY PANEL

CLARINS PARIS

Haute Exigence Jour SPF 20

Super Restorative Day Illuminating lifting replenishing cream All skin types

BROAD SPECTRUM - SPF 20 - Sunscreen

e 50 mL                     1.7 Oz. Net Wt.


PRINCIPAL DISPLAY PANEL

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