ALOE UP NATURAL LIP ICE SUNSCREEN- octinoxate, oxybenzone lipstick

ALOE UP NATURAL LIP ICE SUNSCREEN by

Drug Labeling and Warnings

ALOE UP NATURAL LIP ICE SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Aloe Care International, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:

OCTINOXATE (%)

OXYBENZONE (4.5%)

PURPOSE

PURPOSE:

SUNSCREEN

INDICATIONS & USAGE

INDICATIONS:

HELPS PREVENT SUNBURN.

DOSAGE & ADMINISTRATION

DIRECTIONS:

APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.

USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.

REAPPLY AT LEAST EVERY 2 HOURS.

CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

WARNINGS

WARNINGS:

FOR EXTERNAL USE ONLY. DO NOT USE ON DAMAGED OR BROKEN SKIN. WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE. STOP USE AND ASK A DOCTOR IF RASH OCCURS. KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

INACTIVE INGREDIENT

Other Ingredients:

ALOE BARBADENSIS LEAF JUICE, BEESWAX, BHT, CAPRYLIC/CAPRIC TRIGLYCERIDE, COCOS NUCIFERA (COCONUT) OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HYDROGENATED VEGETABLE OIL, LANOLIN, MANGIFERA INDICA (MANGO) SEED BUTTER, PERSEA GRATISSIMA (AVOCADO) OIL, RICINUS COMMUNIS (CASTOR) SEED OIL, TOCOPHEROL, TOCOPHERYL ACETATE (VITAMIN E)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALOE UP NATURAL LIP ICE SUNSCREEN 
octinoxate, oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61477-214
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4.5   in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YELLOW WAX (UNII: 2ZA36H0S2V)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCONUT OIL (UNII: Q9L0O73W7L)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
LANOLIN (UNII: 7EV65EAW6H)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
AVOCADO OIL (UNII: 6VNO72PFC1)
CASTOR OIL (UNII: D5340Y2I9G)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61477-214-14	4.25 g in 1 TUBE; Type 0: Not a Combination Product	02/24/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/24/2014

Labeler - Aloe Care International, LLC (938242187)

Registrant - Aloe Care International, LLC (938242187)