NDC Code(s) : 58668-7251-1
Packager : Laboratoires Clarins S.A.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clarins Self Tanning Milk With Sun Protection Spf 6OCTINOXATE, AVOBENZONE SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58668-7251
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE60 mg in 1 mL
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
DIHYDROXYACETONE(UNII: O10DDW6JOO)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
GLYCERIN(UNII: PDC6A3C0OX)
DIETHYLHEXYL SUCCINATE(UNII: 69W9UMG3P8)
CETYL ALCOHOL(UNII: 936JST6JCN)
DIMETHICONE(UNII: 92RU3N3Y1O)
SESAME OIL(UNII: QX10HYY4QV)
TOCOPHEROL(UNII: R0ZB2556P8)
C13-14 ISOPARAFFIN(UNII: E4F12ROE70)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
BETULA PUBESCENS BARK(UNII: 3R504894L9)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SORBIC ACID(UNII: X045WJ989B)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
LAURETH-7(UNII: Z95S6G8201)
VANILLA(UNII: Q74T35078H)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SODIUM BENZOATE(UNII: OJ245FE5EU)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58668-7251-11 in 1 PACKAGE
1125 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 08/29/2012

PRINCIPAL DISPLAY PANEL

CLARINS PARIS BROAD SPECTRUM SPF 6 - Sunscreen Self Tanning Milk Hydrates and protects 

CLARINS PARIS - 92200 Neuilly 95300 Pontoise - France Made in France 125 mL   4.2 Fl.Oz.

PRINCIPAL DISPLAY PANEL


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