NDC Code(s) : 70581-003-75
Packager : BPS 60

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Absolue Premium Bx Sunscreen Broad Spectrum SPF 15 Absolute ReplenishingAVOBENZONE, OCTISALATE, OCTOCRYLENE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70581-003
Route of Administration TOPICAL, TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE30 mg in 1 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE30 mg in 1 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE80 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
ALCOHOL(UNII: 3K9958V90M)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
PEG-20 METHYL GLUCOSE SESQUISTEARATE(UNII: 0345752X7U)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
C13-14 ISOPARAFFIN(UNII: E4F12ROE70)
HYDROXYPROPYL TETRAHYDROPYRANTRIOL(UNII: 4U3GMG1OT1)
PADINA PAVONICA(UNII: 177U06NHZI)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW)(UNII: 1394NXB9L6)
STEARIC ACID(UNII: 4ELV7Z65AP)
ADENOSINE(UNII: K72T3FS567)
TROLAMINE(UNII: 9O3K93S3TK)
CALCIUM PANTOTHENATE(UNII: 568ET80C3D)
DIMETHYL ISOSORBIDE(UNII: SA6A6V432S)
XANTHAN GUM(UNII: TTV12P4NEE)
LINALOOL, (+/-)-(UNII: D81QY6I88E)
DIOSCOREA VILLOSA TUBER(UNII: IWY3IWX2G8)
FERRIC OXIDE RED(UNII: 1K09F3G675)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
CAPRYLOYL SALICYLIC ACID(UNII: 5F7PJF6AA4)
PARAFFIN(UNII: I9O0E3H2ZE)
EDETATE DISODIUM(UNII: 7FLD91C86K)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CETYL ALCOHOL(UNII: 936JST6JCN)
OCTYLDODECANOL(UNII: 461N1O614Y)
LAURETH-7(UNII: Z95S6G8201)
HEXYLDECANOL(UNII: 151Z7P1317)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70581-003-751 in 1 BOX 04/09/2016
175 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 04/09/2016

LABELER - BPS 60(272259304)

Establishment
Name Address ID/FEI Business Operations
BPS 60 272259304 pack(70581-003)

PRINCIPAL DISPLAY PANEL

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