NDC Code(s) : 61477-219-11
Packager : Aloe Care International, LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ALOE UP SPORT NATURAL BALM AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE STICK
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61477-219
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE2 g in 100 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE6.5 g in 100 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 g in 100 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE1.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF(UNII: ZY81Z83H0X)
AVOCADO OIL(UNII: 6VNO72PFC1)
YELLOW WAX(UNII: 2ZA36H0S2V)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
CANOLA OIL(UNII: 331KBJ17RK)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
CASTOR OIL(UNII: D5340Y2I9G)
COCONUT OIL(UNII: Q9L0O73W7L)
HYDROGENATED SOYBEAN OIL(UNII: A2M91M918C)
LANOLIN(UNII: 7EV65EAW6H)
MANGIFERA INDICA SEED BUTTER(UNII: 4OXD9M35X2)
SUNFLOWER OIL(UNII: 3W1JG795YI)
TOCOPHEROL(UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61477-219-114.25 g 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

SPORT BALM Natural