NDC Code(s) : 76446-001-75
Packager : Anna Lotan Ltd

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Anna Lotan Triple Benefit Tinted Moisturizing Day Broad Spectrum SPF 30 OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76446-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE7.5 mL in 100 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM - UNII:D1JT611TNE) 		TITANIUM DIOXIDE6.65 mL in 100 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE2.5 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
GLYCERIN(UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
PENTAERYTHRITYL DISTEARATE(UNII: 697WOT8HNB)
PROPANEDIOL(UNII: 5965N8W85T)
SIMMONDSIA CHINENSIS SEED WAX(UNII: 47X6Y9FJJ2)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CHONDRUS CRISPUS(UNII: OQS23HUA1X)
PANTHENOL(UNII: WV9CM0O67Z)
SODIUM STEAROYL GLUTAMATE(UNII: 65A9F4P024)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
BETASIZOFIRAN(UNII: 2X51AD1X3T)
DIMETHICONE(UNII: 92RU3N3Y1O)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
XANTHAN GUM(UNII: TTV12P4NEE)
SODIUM POLYACRYLATE (8000 MW)(UNII: 285CYO341L)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
TOCOPHEROL(UNII: R0ZB2556P8)
CHLORPHENESIN(UNII: I670DAL4SZ)
.BETA.-SITOSTEROL(UNII: S347WMO6M4)
SQUALENE(UNII: 7QWM220FJH)
EDETATE DISODIUM(UNII: 7FLD91C86K)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76446-001-751 in 1 CARTON
175 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/19/2012

PRINCIPAL DISPLAY PANEL

Drug Facts

PRINCIPAL DISPLAY PANEL

www.annalotan-usa.com  12M  PeTA  7 290103 009182  P.O.Box 166 Or Akiva 30600  PRODUCT OF ISRAEL

PRINCIPAL DISPLAY PANEL

A anna lotan  TRIPLE BENEFIT Tinted Moisturizing Day Cream Broad Spectrum  UVA/UVB SPF 30  2.5 fl oz (75 ml.)

PRINCIPAL DISPLAY PANEL

A anna lotan  TRIPLE BENEFIT Tinted Moisturizing Day Cream Broad Spectrum  UVA/UVB SPF 30  2.5 fl oz (75 ml.)

PRINCIPAL DISPLAY PANEL

Anna Lotan 1

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Anna Lotan 2

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Anna Lotan 3

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Anna Lotan Bottle Label