MINT FUSION LIP BALM SPF 30 SUPERGOOP- octinoxate, octisalate, avobenzone cream

Mint Fusion Lip Balm SPF 30 by

Drug Labeling and Warnings

Mint Fusion Lip Balm SPF 30 by is a Otc medication manufactured, distributed, or labeled by TAYLOR JAMES, LTD., Cosway Company Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Avobenzone 3.0% Sunscreen

Ocinoxate 7.5% Sunscreen

Octisalate 5.0% Sunscreen

Helps prevent and temporarily protect chafed, chapped, cracked or windburned skin and/or lips. 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.

Keep out of reach of children

Stop use and ask a doctor if rash occurs

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. If swallowed, get medical help or contact a poison control center right away. If condition worsens or does not improve within 7 days, consult a doctor.

Directions

· Apply liberally 15 minutes before sun exposure

-Reapply liberally as often as necessary

· Use a water resistant sunscreen if swimming or sweating

· Children under 6 months: Ask a doctor

Reapply at least every 2 hours

· 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 broad spectrum SPF of 15 or higher and other sun protection measures
including:
· limit time in the sun, especially from 10 a.m. - 2 p.m.

Inactive Ingredients- Petrolatum, Ozokerite, Beeswax, Polyester-7, Neopentyl Glycol Diheptanoate, Flavor, Sorbitan Oleate, Euphorbia Cerifera (Candelilla) wax, Copernicia cerifera (carnauba) Wax, Polysiilicone-15, Glycine Soja (Soybean) Oil, Tocopherol, Butyrospermum Parkii (Shea) Butter, Honey, Ascorbyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Extract, Ricinus Communis (Castor) Seed Oil, Red 27 Lake, Cocos Nucifera (coconut) Fruit Extract

PRINCIPAL DISPLAY PANEL

Supergoop SPF 30

Soothe

Protect

Hydrate

MintFusion Lip Balm with Shea Butter

.50 Fl Oz

INGREDIENTS AND APPEARANCE

MINT FUSION LIP BALM SPF 30  SUPERGOOP
octinoxate, octisalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.11 g  in 15 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.74 g  in 15 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.44 g  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
CERESIN (UNII: Q1LS2UJO3A)
CANDELILLA WAX (UNII: WL0328HX19)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HONEY (UNII: Y9H1V576FH)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
POLYSILICONE-15 (UNII: F8DRP5BB29)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MENTHONE 1,2-GLYCEROL KETAL, (-)- (UNII: 7V7GIB547Y)
MENTHOL (UNII: L7T10EIP3A)
SPEARMINT OIL (UNII: C3M81465G5)
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-113-02	1 in 1 CARTON	08/31/2012
1	NDC: 75936-113-01	15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/31/2012

Labeler - TAYLOR JAMES, LTD. (033381850)

Registrant - TAYLOR JAMES, LTD. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company Inc		620899877	manufacture(75936-113)