SUN SHADES LIP BALM BUTTER RUM- avobenzone 2.5%, octinoxate 6%, oxybenzone 3% stick

Sun Shades Lip Balm by

Drug Labeling and Warnings

Sun Shades Lip Balm by is a Otc medication manufactured, distributed, or labeled by Melaleuca Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Do not use on damaged or broken skin

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a dcotor if rash occurs

KEEP OUT OF REACH OF CHILDREN

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

STORAGE AND HANDLING

■ 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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUN SHADES LIP BALM  BUTTER RUM
avobenzone 2.5%, octinoxate 6%, oxybenzone 3% stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-214
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.1175 g  in 4.25 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.282 g  in 4.25 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.141 g  in 4.25 g

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
CERESIN (UNII: Q1LS2UJO3A)
CETYL ESTERS WAX (UNII: D072FFP9GU)
COCOA BUTTER (UNII: 512OYT1CRR)
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)
JOJOBA OIL (UNII: 724GKU717M)
PETROLATUM (UNII: 4T6H12BN9U)
YELLOW WAX (UNII: 2ZA36H0S2V)
CANDELILLA WAX (UNII: WL0328HX19)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-214-01	4.25 g in 1 APPLICATOR; Type 0: Not a Combination Product	10/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/01/2012

Labeler - Melaleuca Inc. (139760102)

Registrant - Melaleuca Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca Inc.		079711683	manufacture(54473-214)