MINT CONDITION LIP SHIELD SPF 30 SUPERGOOP- avobenzone, octisalate, homosalate, octinoxate stick

Mint Condition Lip Shield SPF 30 by

Drug Labeling and Warnings

Mint Condition Lip Shield SPF 30 by is a Otc medication manufactured, distributed, or labeled by T AYLO R JAMES, LT D., Filltech USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                    Purpose
Avobenzone 2% ....................... Sunscreen

Octisalate 5% ........................... Sunscreen

Homosalate 15% ..................... Sunscreen

Octinoxate 7.5% ...................... Sunscreen

PURPOSE

Uses Helps prevent and temporarily protect chafed, chapped, cracked, or windburned lips

• Helps preven sunburns
• 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

Keep out of reach of children

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

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

DOSAGE & ADMINISTRATION

Directions Apply liberally 15 minutes before sun exposure

• Reapply: after 80 minutes of swimming or sweating-immediately after towel drying-at least every 2 hours
• Children under 6 months: Ask a doctor

Sun Protection Measures: Spening 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 10a.m. - 2p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

Cera Alba (Beeswax), Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Persea Gratissima (Avocado) OIl, Simmondsia Chenensis (Jojoba) Seed Oil, Flavor, Lanolin, Stevia Rebaudiana Extract, Glycine Soja (Soybean) Oil, Aloe Barbadensis Leaf Juice, Rosmarinus Officinalis (Rosmary) Leaf Extract, Vitis Vinifera (Grape) Seed Oil 

PRINCIPAL DISPLAY PANEL

Mint Condition Lip Shield

Broad Spectrum SPF 30

0.15oz./4.2G

INGREDIENTS AND APPEARANCE

MINT CONDITION LIP SHIELD SPF 30  SUPERGOOP
avobenzone, octisalate, homosalate, octinoxate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WHITE WAX (UNII: 7G1J5DA97F)
COCONUT OIL (UNII: Q9L0O73W7L)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TOCOPHEROL (UNII: R0ZB2556P8)
AVOCADO OIL (UNII: 6VNO72PFC1)
JOJOBA OIL (UNII: 724GKU717M)
LANOLIN (UNII: 7EV65EAW6H)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
SOYBEAN OIL (UNII: 241ATL177A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ROSEMARY (UNII: IJ67X351P9)
GRAPE SEED OIL (UNII: 930MLC8XGG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-201-01	4.2 g in 1 CYLINDER; Type 0: Not a Combination Product	08/08/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/08/2016

Labeler - T AYLO R JAMES, LT D. (033381850)

Registrant - T AYLO R JAMES, LT D. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Filltech USA, LLC		965596435	manufacture(75936-201)