SHINE ON LIP SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octinoxate, octisalate cream

Shine On Lip Sunscreen by

Drug Labeling and Warnings

Shine On Lip Sunscreen 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% ............. Sunscreen

Homosalate 10% ............ Sunscreen

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

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

PURPOSE

Uses

• Helps prevent and tempararily 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

Children under 6 months: Ask a doctor

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

DOSAGE & ADMINISTRATION

Directions

• Apply liberally 15 minuts before sun exposure
• Reapply after 80 minuts of swimming or sweating
• Immediately after towel drying
• At least every two 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 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

Inactive Ingredients

Hydrogenated Polyisobutene, Butyloctyl Salicylate, Polyester-7, Diisopropyl Sebacte, Isodecyl Neopentanoate, Lauryl Lactate, Neopentyl Glycol Diheptanoate, Polyester-8, Tibehenin, Phenoxyethanol, Trihydroxystearin, Menthone Glycerin Acetal, Diethylhexy Syringylidenemalonate, Polybutene, Tocopheryl Acetate, Polysilicone-15, Octyldodecanol, Elaeis Guineensis (Palm) Oil, Benzoic Acid, Tocotrienols, Helianthus Annuus (Sunflower) Seed Oil, Dehydroacetic Acid, Tocopherol, Caprylic/Capric Triglyceride, BHT, Vits Vinifera (Grape) Seed Extract, Laminaria Ochroleuca Extract 

PRINCIPAL DISPLAY PANEL

Shine-On!

Lip Screen

With Grape Polyphenols

Broa Spectrum SPF 50

Supergoop!

Water resistant

(80 minutes)

0.14 fl. oz. / 4 ml.

INGREDIENTS AND APPEARANCE

SHINE ON LIP SUNSCREEN  BROAD SPECTRUM SPF 50
avobenzone, homosalate, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-141
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 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYESTER-7 (UNII: 0841698D2F)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
LAURYL LACTATE (UNII: G5SU0BFK7O)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
MENTHONE 1,2-GLYCEROL KETAL, (+/-)- (UNII: 7QQ1EE6RCP)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYSILICONE-15 (UNII: F8DRP5BB29)
OCTYLDODECANOL (UNII: 461N1O614Y)
PALM OIL (UNII: 5QUO05548Z)
BENZOIC ACID (UNII: 8SKN0B0MIM)
TOCOTRIENOLS (UNII: KP2MW85SSQ)
SUNFLOWER OIL (UNII: 3W1JG795YI)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
TOCOPHEROL (UNII: R0ZB2556P8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-141-02	1 in 1 BOX	01/05/2016
1	NDC: 75936-141-01	4 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 75936-141-03	1.5 mL in 1 TUBE; Type 0: Not a Combination Product	07/19/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/05/2016

Labeler - TAYLOR JAMES, LTD. (033381850)

Registrant - TAYLOR JAMES, LTD. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company Inc.		620899877	manufacture(75936-141)