NDC Code(s) : 37012-465-01
Packager : Shopko Stores Operating Co., LLC Corporate

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sunscreen Lip Balm Avobenzone 2.0% Octisalate 4.0% Octocrylene 10.0% Oxybenzone 6.0% STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:37012-465
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		Avobenzone2.0 g in 100 g
Octisalate(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		Octisalate4.0 g in 100 g
Octocrylene(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		Octocrylene10.0 g in 100 g
Oxybenzone(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		Oxybenzone6.0 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF(UNII: ZY81Z83H0X)
Ascorbic Acid(UNII: PQ6CK8PD0R)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
Cetyl Alcohol(UNII: 936JST6JCN)
PUMMELO(UNII: ET1TN5W71X)
LEMON PEEL(UNII: 72O054U628)
CUCUMBER(UNII: YY7C30VXJT)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
Diisobutyl Adipate(UNII: 8OPY05ZY7S)
Dimethicone(UNII: 92RU3N3Y1O)
EQUISETUM ARVENSE BRANCH(UNII: 1L0VKZ185E)
Ethylhexyl Palmitate(UNII: 2865993309)
GINKGO(UNII: 19FUJ2C58T)
Hydrated Silica(UNII: Y6O7T4G8P9)
MACROCYSTIS PYRIFERA(UNII: K31S3OG5C4)
Mineral Oil(UNII: T5L8T28FGP)
CERESIN(UNII: Q1LS2UJO3A)
ASIAN GINSENG(UNII: CUQ3A77YXI)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
Polysorbate 80(UNII: 6OZP39ZG8H)
Propylene Glycol(UNII: 6DC9Q167V3)
Propylparaben(UNII: Z8IX2SC1OH)
PUNICA GRANATUM ROOT BARK(UNII: CLV24I3T1D)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
ROSEMARY(UNII: IJ67X351P9)
SALIX ALBA BARK(UNII: 205MXS71H7)
SAGE(UNII: 065C5D077J)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
COCOA BUTTER(UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
Water(UNII: 059QF0KO0R)
ISOSTEARYL LINOLEATE(UNII: 4778M3HR0N)
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S)(UNII: R9TPS68K19)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37012-465-012 in 1 BLISTER PACK
14 g in 1 CYLINDER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 03/15/2015

PRINCIPAL DISPLAY PANEL

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