NDC Code(s) : 61995-2384-1
Packager : The Hain Celestial Group, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AL0038400 Alba Botanica Fast Fix Sun SPF30Octocrylene, Octyl Salicylate, Zinc Oxide STICK
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2384
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE20 g in 100 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 g in 100 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE10 g in 100 g
Inactive Ingredients
Ingredient Name Strength
TOCOPHEROL(UNII: R0ZB2556P8)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
GLYCERIN(UNII: PDC6A3C0OX)
SHEA BUTTER(UNII: K49155WL9Y)
CHAMOMILE(UNII: FGL3685T2X)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
POLYSORBATE 60(UNII: CAL22UVI4M)
GLYCERYL MONOBEHENATE(UNII: A626UU0W2A)
CARNAUBA WAX(UNII: R12CBM0EIZ)
COCOA BUTTER(UNII: 512OYT1CRR)
SUNFLOWER OIL(UNII: 3W1JG795YI)
PUNICA GRANATUM SEED OIL(UNII: 0UI45XV0T6)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
COCONUT OIL(UNII: Q9L0O73W7L)
CANDELILLA WAX(UNII: WL0328HX19)
GLYCERYL ABIETATE(UNII: 2F22LY70Q1)
HYDROGENATED JOJOBA OIL, RANDOMIZED(UNII: Q47ST02F58)
RAPHANUS SATIVUS VAR. SATIVUS SEED(UNII: A94I086Q5E)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61995-2384-11 in 1 CARTON 26/12/2017
114 g in 1 CONTAINER 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 12/26/2017

LABELER - The Hain Celestial Group, Inc.(117115556)

REGISTRANT - The Hain Celestial Group, Inc.(014334364)

Establishment
Name Address ID/FEI Business Operations
The Hain Celestial Group, Inc. 081512382 manufacture(61995-2384)

PRINCIPAL DISPLAY PANEL

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