NDC Code(s) : 61477-213-14
Packager : Aloe Care International, LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ALOE UP SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61477-213
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE3 g in 100 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE5 g in 100 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 g in 100 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE6 g in 100 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE10 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: 71DD5V995L)
ALLANTOIN(UNII: 344S277G0Z)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
BUTYLOCTYL SALICYLATE(UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
CAMELLIA SINENSIS WHOLE(UNII: C5M4585ZBZ)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)(UNII: Z135WT9208)
IODOPROPYNYL BUTYLCARBAMATE(UNII: 603P14DHEB)
ISODECYL NEOPENTANOATE(UNII: W60VYE24XC)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
HIGH DENSITY POLYETHYLENE(UNII: UG00KM4WR7)
POLYSORBATE 20(UNII: 7T1F30V5YH)
PROPANEDIOL(UNII: 5965N8W85T)
SORBITOL(UNII: 506T60A25R)
COCOA BUTTER(UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
TROLAMINE(UNII: 9O3K93S3TK)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE(UNII: YA22H34H9Q)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61477-213-14118 mL in 1 TUBE Type 0: Not a Combination Product24/02/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 02/24/2014

LABELER - Aloe Care International, LLC(938242187)

PRINCIPAL DISPLAY PANEL

Aloe Up White 50 4 oz Lotion