NDC Code(s) : 61995-2072-9
Packager : The Hain Celestial Group, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Alba Botanica VE Daily Shade SPF15 BodyAvobenzone, Homosalate, Octisalate, Octocrylene LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2072
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE7.5 g in 100 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 g in 100 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE3 g in 100 g
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
SODIUM BENZOATE(UNII: OJ245FE5EU)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
LACTIC ACID(UNII: 33X04XA5AT)
ALCOHOL(UNII: 3K9958V90M)
BENZYL ALCOHOL(UNII: LKG8494WBH)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
GLYCERIN(UNII: PDC6A3C0OX)
WATER(UNII: 059QF0KO0R)
SHEA BUTTER(UNII: K49155WL9Y)
ECHINACEA PURPUREA ROOT(UNII: OS64WTR4KU)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
GLYCERYL STEARATE SE(UNII: FCZ5MH785I)
SAFFLOWER OIL(UNII: 65UEH262IS)
CETYL ALCOHOL(UNII: 936JST6JCN)
DIMETHICONE(UNII: 92RU3N3Y1O)
ALLANTOIN(UNII: 344S277G0Z)
BENZOIC ACID(UNII: 8SKN0B0MIM)
DEHYDROACETIC ACID(UNII: 2KAG279R6R)
AVOCADO OIL(UNII: 6VNO72PFC1)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CHAMOMILE(UNII: FGL3685T2X)
CUCUMBER(UNII: YY7C30VXJT)
XANTHAN GUM(UNII: TTV12P4NEE)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
GRAPE SEED OIL(UNII: 930MLC8XGG)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP(UNII: 9YT4B71U8P)
GLYCOLIC ACID(UNII: 0WT12SX38S)
HYDROGENATED PALM KERNEL OIL(UNII: FM8D1RE2VP)
SESAME OIL(UNII: QX10HYY4QV)
JOJOBA OIL(UNII: 724GKU717M)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
PANTHENOL(UNII: WV9CM0O67Z)
POLYSORBATE 60(UNII: CAL22UVI4M)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61995-2072-9907 g in 1 BOTTLE Type 0: Not a Combination Product04/11/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 04/11/2017

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

REGISTRANT - The Hain Celestial Group, Inc.(081512382)

Establishment
Name Address ID/FEI Business Operations
Hain-Celestial Canada, ULC 201360821 manufacture(61995-2072)

PRINCIPAL DISPLAY PANEL

bottle label