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Name:Aruba Aloe Lip Sunscreen And Moisturizer
Manufacturer:Aruba Aloe Balm Nv
Category:Over-the-counter (OTC) Marketed Drugs


Aruba Aloe Lip Sunscreen and Moisturizer

ARUBA ALOE LIP SUNSCREEN AND MOISTURIZER  - oxybenzone and padimate o lipstick 
Aruba Aloe Balm NV

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Aruba Aloe Lip Sunscreen and Moisturizer

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).

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

Lip Sunscreen and Moisturizer


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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYBENZONE (OXYBENZONE) OXYBENZONE 3 g  in 100 g
PADIMATE O (PADIMATE O) PADIMATE O 8 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM  
COCOA BUTTER  
YELLOW WAX  
COCONUT OIL  
ALOE VERA LEAF  
ACETATE ION  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53675-140-01 4.8 g in 1 TUBE None

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)

Revised: 06/2011 Aruba Aloe Balm NV



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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