SHINE ON LIP SUNSCREEN  BROAD SPECTRUM SPF 50- avobenzone, homosalate, octinoxate, octisalate cream 
TAYLOR JAMES, LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Shine-On Lip Sunscreen Broad Spectrum SPF 50

Active Ingredients             Purpose

Avobenzone 3% ............. Sunscreen

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

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

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

Uses

Children under 6 months: Ask a doctor

Stop use and ask a doctor if rash occurs

Warnings

Directions

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:

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 

Shine-On!

Lip Screen

With Grape Polyphenols

Broa Spectrum SPF 50

Supergoop!

Water resistant

(80 minutes)

0.14 fl. oz. / 4 ml.

image description

SHINE ON LIP SUNSCREEN   BROAD SPECTRUM SPF 50
avobenzone, homosalate, octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-141
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-141-021 in 1 BOX01/05/2016
1NDC:75936-141-014 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:75936-141-031.5 mL in 1 TUBE; Type 0: Not a Combination Product07/19/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/05/2016
Labeler - TAYLOR JAMES, LTD. (033381850)
Registrant - TAYLOR JAMES, LTD. (033381850)
Establishment
NameAddressID/FEIBusiness Operations
Cosway Company Inc.052400223manufacture(75936-141)

Revised: 11/2020
Document Id: b3ef6a00-1d76-3b97-e053-2995a90a56fe
Set id: aae55362-69bc-4b8f-a3c1-f0a61d0b06c4
Version: 5
Effective Time: 20201112
 
TAYLOR JAMES, LTD.