NDC Code(s) : 41167-0625-0
Packager : Chattem, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Gold Bond Ultimate ProtectionAvobenzone and Homosalate and Octisalate and Octocrylene LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:41167-0625
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 g
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE5 g in 100 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE4 g in 100 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
METHYL GLUCETH-20(UNII: J3QD0LD11P)
CETYL ALCOHOL(UNII: 936JST6JCN)
STEARETH-21(UNII: 53J3F32P58)
STEARETH-2(UNII: V56DFE46J5)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
C13-14 ISOPARAFFIN(UNII: E4F12ROE70)
DIMETHICONE(UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE, D-(UNII: A7E6112E4N)
LAURETH-7(UNII: Z95S6G8201)
SHEA BUTTER(UNII: K49155WL9Y)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
PANTHENOL(UNII: WV9CM0O67Z)
MAGNESIUM ASCORBYL PHOSPHATE(UNII: 0R822556M5)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
SUCROSE(UNII: C151H8M554)
LEMON(UNII: 24RS0A988O)
ORANGE(UNII: 5EVU04N5QU)
LAVANDULA ANGUSTIFOLIA FLOWER(UNII: 19AH1RAF4M)
MATRICARIA RECUTITA(UNII: G0R4UBI2ZZ)
ROSEMARY(UNII: IJ67X351P9)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
BENZYL ALCOHOL(UNII: LKG8494WBH)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
EDETIC ACID(UNII: 9G34HU7RV0)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:41167-0625-0368 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 03/01/2008

PRINCIPAL DISPLAY PANEL

GOLD BOND® ULTIMATE protection
SKIN THERAPY LOTION
SPF 15
PROTECTS & PREVENTS DAILY UV SUN DAMAGE
Net wt 13 oz (368 g)

PRINCIPAL DISPLAY PANEL GOLD BOND® ULTIMATE protection SKIN THERAPY LOTION SPF 15 PROTECTS & PREVENTS DAILY UV SUN DAMAGE Net wt 13 oz (368 g)