NDC Code(s) : 61995-3012-1
Packager : The Hain Celestial Group, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Alba Botanica Even Advanced Moisturizer SPF15Avobenzone, Octisalate, Octocrylene LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-3012
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 g in 100 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE10 g in 100 g
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
HYDROLYZED ULVA COMPRESSA PROTEIN (ACID; 300-5000 MW)(UNII: Q04O53779D)
PRUNELLA VULGARIS FLOWER(UNII: AT1FD041EF)
LINALOOL, (+)-(UNII: F4VNO44C09)
DIACETYL BOLDINE(UNII: 37727Z7M0I)
LIMONENE, (+)-(UNII: GFD7C86Q1W)
CINNAMYLAMINE(UNII: 7360F8GA70)
COUMARIN(UNII: A4VZ22K1WT)
SODIUM LEVULINATE(UNII: VK44E1MQU8)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
SODIUM BENZOATE(UNII: OJ245FE5EU)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ASCORBYL GLUCOSIDE(UNII: 2V52R0NHXW)
CAESALPINIA SPINOSA RESIN(UNII: WL3883U2PO)
ERYTHRITOL(UNII: RA96B954X6)
HOMARINE HYDROCHLORIDE(UNII: 8866LNG61N)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
LAMINARIA DIGITATA(UNII: 15E7C67EE8)
ULVA LACTUCA(UNII: PHR3P25W6Y)
SODIUM STEAROYL GLUTAMATE(UNII: 65A9F4P024)
ALCOHOL(UNII: 3K9958V90M)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
GLYCERIN(UNII: PDC6A3C0OX)
WATER(UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
XANTHAN GUM(UNII: TTV12P4NEE)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
COCO-CAPRYLATE/CAPRATE(UNII: 8D9H4QU99H)
LINALYL ACETATE(UNII: 5K47SSQ51G)
LECITHIN, SUNFLOWER(UNII: 834K0WOS5G)
PULLULAN(UNII: 8ZQ0AYU1TT)
HYDRATED SILICA(UNII: Y6O7T4G8P9)
CITRUS AURANTIUM FRUIT OIL(UNII: 59JDQ5VT0T)
MALVA SYLVESTRIS FLOWER(UNII: 12X9JI52BS)
MELISSA OFFICINALIS LEAF OIL(UNII: PTP6R7263M)
MENTHA PIPERITA LEAF(UNII: A389O33LX6)
ORYZA SATIVA WHOLE(UNII: 84IVV0906Z)
PRIMULA VERIS WHOLE(UNII: W6LFQ57E4M)
VERONICA OFFICINALIS WHOLE(UNII: 9EHR580PSP)
CAPRYLIC/CAPRIC ACID(UNII: DI775RT244)
CYAMOPSIS TETRAGONOLOBA WHOLE(UNII: K97Q182I2L)
GLYCERYL CAPRATE(UNII: 197M6VFC1W)
CLAVICEPS PURPUREA SCLEROTIUM(UNII: 01G9XEA93N)
SODIUM ANISATE(UNII: F9WFJ28MV9)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
COCONUT ALKANES(UNII: 1E5KJY107T)
BIOSACCHARIDE GUM-1(UNII: BB4PU4V09H)
ACHILLEA MILLEFOLIUM FLOWER(UNII: YQR8R0SQEA)
ACHILLEA MILLEFOLIUM WHOLE(UNII: 2FXJ6SW4PK)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
SHEA BUTTER ETHYL ESTERS(UNII: V2CI786FPG)
CUCUMIS SATIVUS WHOLE(UNII: 50560UL2YV)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61995-3012-11 in 1 CARTON 17/08/2016
157 g in 1 TUBE 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 08/17/2016

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

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

Establishment
Name Address ID/FEI Business Operations
The Hain Celestial Group, Inc. 081512382 manufacture(61995-3012)

PRINCIPAL DISPLAY PANEL

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