NDC Code(s) : 52261-1500-4, 52261-1500-1
Packager : Cosco International, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Smart Stuff Natural Lip Treatment SPF15 4gzinc oxide LIPSTICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52261-1500
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION0.462 g in 4.62 g
Inactive Ingredients
Ingredient Name Strength
HYDROGENATED SOYBEAN OIL(UNII: A2M91M918C)1.33473879 g in 4.62 g
HYDROGENATED OLIVE OIL(UNII: 53839415GI)0.75920922 g in 4.62 g
WHITE WAX(UNII: 7G1J5DA97F)0.6237 g in 4.62 g
HYDROGENATED JOJOBA OIL(UNII: 7F674YQ5SO)0.46983321 g in 4.62 g
DIHEPTYL SUCCINATE(UNII: 057N7SS26Y)0.44352 g in 4.62 g
CARNAUBA WAX(UNII: R12CBM0EIZ)0.231 g in 4.62 g
CETYL ALCOHOL(UNII: 936JST6JCN)0.1155 g in 4.62 g
SHEA BUTTER(UNII: K49155WL9Y)0.0693 g in 4.62 g
AVOCADO OIL(UNII: 6VNO72PFC1)0.0462 g in 4.62 g
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)0.0231 g in 4.62 g
POLIFEPROSAN 20(UNII: S40C40DA21)0.01848 g in 4.62 g
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)0.01493184 g in 4.62 g
COCONUT OIL(UNII: Q9L0O73W7L)0.00462 g in 4.62 g
SOY STEROL(UNII: PL360EPO9J)0.00386694 g in 4.62 g
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52261-1500-11 in 1 BOX
1NDC:52261-1500-44 g in 1 CYLINDER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 03/18/2016

PRINCIPAL DISPLAY PANEL

PDP