NDC Code(s) : 47124-333-01
Packager : Wegman

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sheer Sunscreen SPF 50 Homosalate - 6.00% Octinoxate - 7.50% Octisalate - 5.00% Octocrylene - 10.00% Zinc Oxide - 8.00% STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47124-333
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Homosalate(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		Homosalate6 g in 100 g
Octinoxate(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		Octinoxate7.5 g in 100 g
Octisalate(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		Octisalate5 g in 100 g
Octocrylene(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		Octocrylene10 g in 100 g
Zinc Oxide(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION8 g in 100 g
Inactive Ingredients
Ingredient Name Strength
1,2-Hexanediol(UNII: TR046Y3K1G)
Aloe(UNII: V5VD430YW9)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
Caprylyl Glycol(UNII: 00YIU5438U)
Ceresin(UNII: Q1LS2UJO3A)
CARNAUBA WAX(UNII: R12CBM0EIZ)
Dimethicone(UNII: 92RU3N3Y1O)
Ethyl Macadamiate(UNII: ANA2NCS6V1)
Ethylhexyl Palmitate(UNII: 2865993309)
HELIANTHUS ANNUUS SEED WAX(UNII: 42DG15CHXV)
HYDROGENATED POLYBUTENE (1300 MW)(UNII: 7D1YQ9Y5EZ)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP(UNII: 9YT4B71U8P)
CHAMOMILE FLOWER OIL(UNII: 60F80Z61A9)
Mineral Oil(UNII: T5L8T28FGP)
Octyldodecanol(UNII: 461N1O614Y)
ALMOND OIL(UNII: 66YXD4DKO9)
Sorbitan Sesquioleate(UNII: 0W8RRI5W5A)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
Triethoxycaprylylsilane(UNII: LDC331P08E)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:47124-333-0114.2 g in 1 TUBE Type 0: Not a Combination Product03/01/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/03/2013

PRINCIPAL DISPLAY PANEL

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