NDC Code(s) : 23667-802-01
Packager : Formulated Solutions, LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Copperstone Water Babies Pure and Simple Whipped Sunscreen Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:23667-802
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE30 mg in 1 g
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE100 mg in 1 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE45 mg in 1 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE40 mg in 1 g
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE60 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
WATER(UNII: 059QF0KO0R)
DOCOSANOL(UNII: 9G1OE216XY)
GLYCERIN(UNII: PDC6A3C0OX)
DICAPRYLYL ETHER(UNII: 77JZM5516Z)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
CETYL ALCOHOL(UNII: 936JST6JCN)
BENZYL ALCOHOL(UNII: LKG8494WBH)
PALMITIC ACID(UNII: 2V16EO95H1)
STEARIC ACID(UNII: 4ELV7Z65AP)
MYRISTYL ALCOHOL(UNII: V42034O9PU)
CHLORPHENESIN(UNII: I670DAL4SZ)
TOCOPHEROL(UNII: R0ZB2556P8)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(UNII: K679OBS311)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
LAURYL ALCOHOL(UNII: 178A96NLP2)
SODIUM ASCORBYL PHOSPHATE(UNII: 836SJG51DR)
NITROUS OXIDE(UNII: K50XQU1029)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:23667-802-01142 g in 1 CAN Type 0: Not a Combination Product02/09/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 02/09/2017

LABELER - Formulated Solutions, LLC(143266687)

PRINCIPAL DISPLAY PANEL

Coppertone Water