NDC Code(s) : 76261-125-01
Packager : Australian Skin Products pty ltd

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ASAP Skin Products Octocrylene,Zinc Oxide, Avobenzone, Ensulizone, Titanium Dioxide LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76261-125
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE6 g in 100 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE2.75 g in 100 mL
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE2 g in 100 mL
ENSULIZOLE(UNII: 9YQ9DI1W42)
(ENSULIZOLE - UNII:9YQ9DI1W42) 		ENSULIZOLE1.5 g in 100 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
OCTOCRYLENE(UNII: 5A68WGF6WM)
NIACINAMIDE(UNII: 25X51I8RD4)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
C13-14 ISOPARAFFIN(UNII: E4F12ROE70)
LAURETH-7(UNII: Z95S6G8201)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
AVOBENZONE(UNII: G63QQF2NOX)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
POLYSORBATE 20(UNII: 7T1F30V5YH)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
GLYCERIN(UNII: PDC6A3C0OX)
DIMETHICONE(UNII: 92RU3N3Y1O)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
METHYLPARABEN(UNII: A2I8C7HI9T)
GLYCERYL ISOSTEARATE(UNII: HYE7O27HAO)
CITRUS RETICULATA FRUIT OIL(UNII: 25P9H3QU5E)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
EDETATE DISODIUM(UNII: 7FLD91C86K)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76261-125-01100 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/03/2011

PRINCIPAL DISPLAY PANEL

image of front label


Moisturising daily defense SPF 30+

With antioxidants

Broad spectrum
sunscreen lotion
UVA +UVB protection

100mL 3.38fl oz.