ALOE UP MEDICATED LIP ICE SUNSCREEN SPF 30- homosalate, meradimate, octinoxate, oxybenzone lipstick

ALOE UP MEDICATED LIP ICE SUNSCREEN by

Drug Labeling and Warnings

ALOE UP MEDICATED 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 INGREDIENTS:

HOMOSALATE (6%)

MERADIMATE (4%)

OCTINOXATE (7.5%)

OXYBENZONE (4.5%)

PURPOSE:

SUNSCREEN

USES

HELPS PREVENT SUNBURN.

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. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

WARNINGS:

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
For external use only
Do not use on damaged or broken skin
Stop use and ask a doctor if rash occurs
When using this product keep out of eyes. Rinse with water to remove.

INACTIVE INGREDIENTS

ALOE VERA OIL, CAMPHOR, CETYL ALCOHOL, MENTHOL, MINERAL OIL, OZOKERITE WAX, PETROLATUM, TITANIUM DIOXIDE, TOCOPHEROL

OTHER INFORMATION

Protect this product from excessive heat and direct sun

Questions or comments?

Toll Free 800-950-2563 www.aloeup.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALOE UP MEDICATED LIP ICE SUNSCREEN  SPF 30
homosalate, meradimate, octinoxate, oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61477-215
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6 g  in 100 g
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ)	MERADIMATE	4 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CETYL ALCOHOL (UNII: 936JST6JCN)
MENTHOL (UNII: L7T10EIP3A)
MINERAL OIL (UNII: T5L8T28FGP)
CERESIN (UNII: Q1LS2UJO3A)
PETROLATUM (UNII: 4T6H12BN9U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61477-215-14	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)