ARUBA ALOE LIP SUNSCREEN AND MOISTURIZER- oxybenzone, padimate lipstick

Aruba Aloe Lip Sunscreen and Moisturizer by

Drug Labeling and Warnings

Aruba Aloe Lip Sunscreen and Moisturizer by is a Otc medication manufactured, distributed, or labeled by Aruba Aloe Balm NV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Oxybenzone 3.0% and Padimate O 8.0%

Use

Helps prevent sunburn

Warnings

Stop use if skin rash occurs

Inactive Ingredients

Petrolatum, Cocoa Butter, Canderila Wax, Beeswax, Coconut Oil, Aruba Aloe Vera Gel, Tocopheryl Acetate (Vitamin E Acetate).

SPL UNCLASSIFIED SECTION

DISTRIBUTED IN THE U.S.A. BY ARUBA ALOE OF  NORTH AMERICA, LLC, INDIANAPOLIS, IN 46244

MADE IN ARUBA

TO REPORT A SERIOUS ADVERSE EVENT CONTACT 1-800-95-ARUBA

www.ArubaAloe.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARUBA ALOE LIP SUNSCREEN AND MOISTURIZER 
oxybenzone, padimate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53675-140
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g  in 100 g
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)	PADIMATE O	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
COCOA BUTTER (UNII: 512OYT1CRR)
YELLOW WAX (UNII: 2ZA36H0S2V)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ACETATE ION (UNII: 569DQM74SC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53675-140-01	4.8 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2011

Labeler - Aruba Aloe Balm NV (855442273)