NDC Code(s) : 43479-205-15, 43479-205-55
Packager : KATE SOMERVILLE SKINCARE, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BODY GLOW SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43479-205
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE3 g in 100 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE7.5 g in 100 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 g in 100 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE2.5 g in 100 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE4 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
NEOPENTYL GLYCOL DIETHYLHEXANOATE(UNII: U68ZV6W62C)
DIISOPROPYL DILINOLEATE(UNII: 5323S7S2LR)
PROPANEDIOL(UNII: 5965N8W85T)
DIMETHICONE(UNII: 92RU3N3Y1O)
MANGIFERA INDICA SEED BUTTER(UNII: 4OXD9M35X2)
PEG/PPG-20/15 DIMETHICONE(UNII: 06R6X77P9C)
PEG/PPG-25/25 DIMETHICONE(UNII: ND6MYD0T84)
SHEA BUTTER(UNII: K49155WL9Y)
ETHYL METHICONE (8 MPA.S)(UNII: 3YWG8XYT8H)
SUNFLOWER OIL(UNII: 3W1JG795YI)
ETHYL FERULATE(UNII: 5B8915UELW)
POLYGLYCERYL-4 OLEATE(UNII: 15B05TY4GX)
ROSEMARY(UNII: IJ67X351P9)
URIDINE MONOPHOSPHATE DISODIUM(UNII: KD8E20071T)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CAFFEINE(UNII: 3G6A5W338E)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
CARRAGEENAN(UNII: 5C69YCD2YJ)
CARBOMER 940(UNII: 4Q93RCW27E)
AMINOMETHYLPROPANOL(UNII: LU49E6626Q)
XANTHAN GUM(UNII: TTV12P4NEE)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM(UNII: 7FLD91C86K)
EGG PHOSPHOLIPIDS(UNII: 1Z74184RGV)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE(UNII: D2QHA03458)
CHONDRUS CRISPUS CARRAGEENAN(UNII: UE856F2T78)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CITRONELLAL(UNII: QB99VZZ7GZ)
GERANIOL(UNII: L837108USY)
.ALPHA.-HEXYLCINNAMALDEHYDE(UNII: 7X6O37OK2I)
LIMONENE, (+)-(UNII: GFD7C86Q1W)
LINALOOL, (+/-)-(UNII: D81QY6I88E)
MICA(UNII: V8A1AW0880)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43479-205-551 in 1 BOX
1NDC:43479-205-15150 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 06/22/2014

PRINCIPAL DISPLAY PANEL

BODY GLOW SUNSCREEN