LIP AND CHEEK TREAT BROAD SPECTRUM SPF 40 SUPERGOOP- avobenzone, homosalate, octinoxate, octisalate stick

Lip and Cheek Treat Broad Spectrum SPF 40 by

Drug Labeling and Warnings

Lip and Cheek Treat Broad Spectrum SPF 40 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%, Homosalate 10%,

Octinoxate 7.5%, Octisalate 5% ....... Sunscreen

PURPOSE

Uses

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

• Helps prevent subnurn
• If use as directed with other sun pretction 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 Posion 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 liberally as oftenas necessary
• Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
• Children under 6 months: 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.
• Weare long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

Butyrospermum Parkii (Shea) Butter, Hydrogenated Polyisobutene, Synthetic Beeswax, Microcrystalline Wax, Polyester-8, Ozokerite, Silica, VP/Hexadecene Copolymer, Ricinus Communis (Castor) Seed Oil, Diisopropyl Sebacate, Isodecyl Neopentanoate, Lauryl Lactate, Hydorgenated Vegetable Oil, Phenoxyethanol, Diethylhexyl Syringylidenemalonate, Titanium Dioxide, Red 7, Tocopherol, Glycine Soja (Soybean) Oil, Yellow 5 Lake, Benzoic Acid, Polysilicone-15, Helianthus Annuus (Sunflower) Seed Oil, Dehydoacetic Acid, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Citric Acid, BHT, Olea Europaea (Olive) Fruit Oil, Pesea Gratissima (Avocado) Oil, Camellia Sinensis Leaf Extract, Water, Calendula Officinalis Flower Extract, Salicylic Acid, Sodium Hydroxide

PRINCIPAL DISPLAY PANEL

Perk Up

Lip & Cheek Treat

Broad Spectrum Sunscreen SPF 40

0.06 oz./ 4.5g

INGREDIENTS AND APPEARANCE

LIP AND CHEEK TREAT BROAD SPECTRUM SPF 40  SUPERGOOP
avobenzone, homosalate, octinoxate, octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-503
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SHEA BUTTER (UNII: K49155WL9Y)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
CERESIN (UNII: Q1LS2UJO3A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
CASTOR OIL (UNII: D5340Y2I9G)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
LAURYL LACTATE (UNII: G5SU0BFK7O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TOCOPHEROL (UNII: R0ZB2556P8)
SOYBEAN OIL (UNII: 241ATL177A)
BENZOIC ACID (UNII: 8SKN0B0MIM)
POLYSILICONE-15 (UNII: F8DRP5BB29)
SUNFLOWER OIL (UNII: 3W1JG795YI)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
CRANBERRY (UNII: 0MVO31Q3QS)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
OLIVE OIL (UNII: 6UYK2W1W1E)
AVOCADO OIL (UNII: 6VNO72PFC1)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
WATER (UNII: 059QF0KO0R)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-503-01	1.5 g in 1 CYLINDER; Type 0: Not a Combination Product	11/04/2016
2	NDC: 75936-503-02	4.5 g in 1 CYLINDER; Type 0: Not a Combination Product	11/04/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/04/2016

Labeler - TAYLOR JAMES, LTD. (033381850)

Registrant - TAYLOR JAMES, LTD. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company Inc.		620899877	manufacture(75936-503)