ALOE UP WHITE LINE MEDICATED LIP BALM SPF 30- octinoxate, homosalate, meradimate and oxybenzone lipstick
Aloe Care International, LLC

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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ACTIVE INGREDIENTS:

HOMOSALATE (6%)

MERADIMATE (4%)

OCTINOXATE (%)

OXYBENZONE (4.5%)

PURPOSE:

SUNSCREEN

INDICATIONS:

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.

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.

Other Ingredients:

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

Aloe Up White Line SPF 30 Medicated Lip Balm

ALOE UP WHITE LINE MEDICATED LIP BALM SPF 30
homosalate, meradimate, octinoxate, oxybenzone lipstick

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (OCTINOXATE)	OCTINOXATE	7.5 g in 100 g
HOMOSALATE (HOMOSALATE)	HOMOSALATE	6 in 100 g
MERADIMATE (MERADIMATE)	MERADIMATE	4 in 100 g
OXYBENZONE (OXYBENZONE)	OXYBENZONE	5 in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF
CAMPHOR (SYNTHETIC)
CETYL ALCOHOL
MENTHOL
MINERAL OIL
CERESIN
PETROLATUM
TITANIUM DIOXIDE
TOCOPHEROL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61477-215-14	4.25 g in 1 TUBE

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

Labeler - Aloe Care International, LLC (938242187)

Registrant - Aloe Care International, LLC (938242187)

Revised: 2/2014

Document Id: 194d7ff8-aa57-4362-8e84-38b312767792

Set id: 639e5509-f02c-499a-b455-bab656073d44

Version: 2

Effective Time: 20140226

Aloe Care International, LLC