NDC Code(s) : 17518-004-01
Packager : 3M Health Care

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SPF 50 Broad Spectrum Homosalate, Octinoxate, Octisalate, Octocrylene, Zinc Oxide STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17518-004
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide8 g in 100 g
Homosalate(UNII: V06SV4M95S)
(Homosalate - UNII:V06SV4M95S) 		Homosalate6 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
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate7.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF(UNII: ZY81Z83H0X)
CHAMOMILE(UNII: FGL3685T2X)
C12-15 ALKYL BENZOATE(UNII: A9EJ3J61HQ)
Carnauba wax(UNII: R12CBM0EIZ)
Dimethicone(UNII: 92RU3N3Y1O)
Ethyl Macadamiate(UNII: ANA2NCS6V1)
Propylparaben(UNII: Z8IX2SC1OH)
Peppermint Oil(UNII: AV092KU4JH)
Ethyl Palmitate(UNII: IRD3M534ZM)
Octyldodecanol(UNII: 461N1O614Y)
Vitamin A Palmitate(UNII: 1D1K0N0VVC)
Sorbitan Sesquioleate(UNII: 0W8RRI5W5A)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:17518-004-011 in 1 BLISTER PACK
114 g in 1 CYLINDER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 04/09/2012

PRINCIPAL DISPLAY PANEL

3M Ultrathon Outdoor Broad Spectrum SPF 50. Water Resistant (40 Minutes).

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