Your browser does not support JavaScript! SUN SHADES LIP BALM PEACH MANGO (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]
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SUN SHADES LIP BALM PEACH MANGO (avobenzone 2.5%, octinoxate 6%, oxybenzone 3%) stick
[Melaleuca Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredients

Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%

Purpose

Sunscreen

Uses

■ helps prevent sunburn ■ if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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 dcotor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ apply liberally 15 minutes before sun exposure

■ reapply at least every 2 hours ■ use a water-resistant sunscreen if swimming or sweating ■ children under 6 months of age: ask a doctor

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF value of 15 or higher and other sun protection measures including: ■ limit time in the sun, especially from 10 a.m.-2 p.m.■ wear long-sleeve shirts, pants, hats, and sunglasses

Other information

■ dermatologist and allergy tested

■ protect this product from excessive heat and direct sun ■ do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

Inactive Ingredients

ammonium glycyrrhizate, beeswax, C12-15 alkyl benzoate, cetyl esters, ethylene/VA copolymer, euphorbia cerifera (candillia) wax, flavor petrolatum USP, simmondsia chinensis (jojoba) seed oil, stearyl dimethicone, theobroma cacao (cocoa) seed butter, tocopheryl acetate (vitamin E USP)

Lip balm label

SUN SHADES LIP BALM  PEACH MANGO
avobenzone 2.5%, octinoxate 6%, oxybenzone 3% stick
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54473-245
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE0.1175 g  in 4.25 g
OCTINOXATE (OCTINOXATE) OCTINOXATE0.282 g  in 4.25 g
OXYBENZONE (OXYBENZONE) OXYBENZONE0.141 g  in 4.25 g
Inactive Ingredients
Ingredient NameStrength
ALKYL (C12-15) BENZOATE 
ALPHA-TOCOPHEROL ACETATE 
AMMONIUM GLYCYRRHIZATE 
CERESIN 
CETYL ESTERS WAX 
COCOA BUTTER 
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) 
JOJOBA OIL 
PETROLATUM 
YELLOW WAX 
CANDELILLA WAX 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-245-014.25 g in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/01/2013
Labeler - Melaleuca Inc. (139760102)
Registrant - Melaleuca Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca Inc.079287544manufacture(54473-245)

Revised: 4/2014
 
Melaleuca Inc.

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