ALOE UP WHITE LINE NATURAL LIP BALM SPF 15- octinoxate 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:

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 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)

Aloe Up White Line SPF 15 Natural Lip Balm

ALOE UP WHITE LINE NATURAL LIP BALM  SPF 15
octinoxate, oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61477-214
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE2 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE4.5   in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
YELLOW WAX 
BUTYLATED HYDROXYTOLUENE 
MEDIUM-CHAIN TRIGLYCERIDES 
COCONUT OIL 
SUNFLOWER OIL 
HYDROGENATED SOYBEAN OIL 
LANOLIN 
MANGIFERA INDICA SEED BUTTER 
AVOCADO OIL 
CASTOR OIL 
TOCOPHEROL 
.ALPHA.-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61477-214-144.25 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/24/2014
Labeler - Aloe Care International, LLC (938242187)
Registrant - Aloe Care International, LLC (938242187)

Revised: 2/2014
 
Aloe Care International, LLC