FDA.reportPublic FDA data

Shine On Lip Sunscreen

Manufacturer
TAYLOR JAMES, LTD. | Cosway Company Inc.
Effective date
2020-11-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:33:27

Label at a glance#

ProductShine On Lip Sunscreen Broad Spectrum SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients             Purpose

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

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

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

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

OTC - PURPOSE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children under 6 months: Ask a doctor

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

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 SECTION

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 SECTION

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 

PACKAGE LABEL.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.

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75936-141-022022-01-28C16284748780-1d6a99b39-98e8-a426-e053-dadaa90af4c2Shine-On Lip Sunscreen Broad Spectrum SPF 50
75936-141-032022-01-28C16284748780-1d6a99b39-98e8-a426-e053-dadaa90af4c2Shine-On Lip Sunscreen Broad Spectrum SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75936-141-01Shine On Lip SunscreenBroad Spectrum SPF 504 mL in 1 BOTTLECREAM45
75936-141-02Shine On Lip SunscreenBroad Spectrum SPF 501 in 1 BOXCREAM15
75936-141-03Shine On Lip SunscreenBroad Spectrum SPF 501.5 mL in 1 TUBECREAM1.55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75936-141SHINE ON LIP SUNSCREEN BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE) CREAM [TAYLOR JAMES, LTD.]5Legacy NDC, 3 package rows20201113_aae55362-69bc-4b8f-a3c1-f0a61d0b06c4.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75936-14175936-141-01, 75936-141-02, 75936-141-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
POLYESTER-70841698D2FIACT
DIISOPROPYL SEBACATEJ8T3X564IHIACT
ISODECYL NEOPENTANOATEW60VYE24XCIACT
LAURYL LACTATEG5SU0BFK7OIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
TRIBEHENIN8OC9U7TQZ0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
TRIHYDROXYSTEARIN06YD7896S3IACT
MENTHONE 1,2-GLYCEROL KETAL, (+/-)-7QQ1EE6RCPIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYSILICONE-15F8DRP5BB29IACT
OCTYLDODECANOL461N1O614YIACT
PALM OIL5QUO05548ZIACT
BENZOIC ACID8SKN0B0MIMIACT
TOCOTRIENOLSKP2MW85SSQIACT
SUNFLOWER OIL3W1JG795YIIACT
DEHYDROACETIC ACID2KAG279R6RIACT
TOCOPHEROLR0ZB2556P8IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
LAMINARIA OCHROLEUCA4R2124HE76IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b3ef6a00-1d76-3b97-e053-2995a90a56feaae55362-69bc-4b8f-a3c1-f0a61d0b06c42020-11-12WarningsExact identifier
spl id: b3ef6a00-1d76-3b97-e053-2995a90a56fe
spl set id: aae55362-69bc-4b8f-a3c1-f0a61d0b06c4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.