NDC Code(s) : 52261-2502-0, 52261-2502-1
Packager : Cosco International, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Smart Stuff SPF30 4ozzinc oxide LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52261-2502
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 CATION23.7 g in 118.294 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)49.4 g in 118.294 g
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)11.8 g in 118.294 g
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)9.5 g in 118.294 g
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)9.0 g in 118.294 g
PHENOXYETHANOL(UNII: HIE492ZZ3T)8.1 g in 118.294 g
OLIVE OIL(UNII: 6UYK2W1W1E)6.0 g in 118.294 g
AVOCADO OIL(UNII: 6VNO72PFC1)6.0 g in 118.294 g
MACADAMIA OIL(UNII: 515610SU8C)6.0 g in 118.294 g
XANTHAN GUM(UNII: TTV12P4NEE)6.0 g in 118.294 g
DIHEPTYL SUCCINATE(UNII: 057N7SS26Y)5.723 g in 118.294 g
GLYCERIN(UNII: PDC6A3C0OX)3.5 g in 118.294 g
POLYGLYCERYL-3 DIISOSTEARATE(UNII: 46P231IQV8)3.0 g in 118.294 g
CETYL ALCOHOL(UNII: 936JST6JCN)2.4 g in 118.294 g
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)1.4 g in 118.294 g
EMU OIL(UNII: 344821WD61)1.2 g in 118.294 g
POLYGLYCERYL-10 OLEATE(UNII: 55C81W76DH)1.05 g in 118.294 g
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)0.9 g in 118.294 g
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)0.525 g in 118.294 g
SODIUM STEAROYL LACTYLATE(UNII: IN99IT31LN)0.525 g in 118.294 g
POLIFEPROSAN 20(UNII: S40C40DA21)0.177 g in 118.294 g
PHYTATE SODIUM(UNII: 88496G1ERL)0.1 g in 118.294 g
CHAMOMILE(UNII: FGL3685T2X)0.1 g in 118.294 g
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52261-2502-11 in 1 BOX
1NDC:52261-2502-0118.294 g in 1 TUBE 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 06/04/2015

PRINCIPAL DISPLAY PANEL

PDP