FDA.reportPublic FDA data

Lip and Cheek Treat Broad Spectrum SPF 40

Manufacturer
TAYLOR JAMES, LTD. | Cosway Company Inc.
Effective date
2017-01-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:48:28

Label at a glance#

ProductLip and Cheek Treat Broad Spectrum SPF 40 Supergoop
Active ingredientAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                           Purpose

Avobenzone 3%, Homosalate 10%,

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

OTC - PURPOSE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

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
  • 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 SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Perk Up

Lip & Cheek Treat

Broad Spectrum Sunscreen SPF 40

0.06 oz./ 4.5g

FrontFront

bottom labelbottom label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75936-503-012021-01-29C16284748780-1ba0f9c33-4a91-a910-e053-dadaa90a0b85Lip & Cheek Treat Broad Spectrum Sunscreen SPF 40
75936-503-022021-01-29C16284748780-1ba0f9c33-4a91-a910-e053-dadaa90a0b85Lip & Cheek Treat Broad Spectrum Sunscreen SPF 40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75936-503-01Lip and Cheek Treat Broad Spectrum SPF 40Supergoop1.5 g in 1 CYLINDERSTICK1.52
75936-503-02Lip and Cheek Treat Broad Spectrum SPF 40Supergoop4.5 g in 1 CYLINDERSTICK4.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75936-503LIP AND CHEEK TREAT BROAD SPECTRUM SPF 40 SUPERGOOP (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE) STICK [TAYLOR JAMES, LTD.]2Legacy NDC, 2 package rows20170117_2bd43f78-2a3f-4072-a7e7-33e1848c6b55.zip

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75936-50375936-503-01, 75936-503-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
SHEA BUTTERK49155WL9YIACT
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
SYNTHETIC WAX (1200 MW)Q3Z4BCH099IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
CERESINQ1LS2UJO3AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
CASTOR OILD5340Y2I9GIACT
DIISOPROPYL SEBACATEJ8T3X564IHIACT
ISODECYL NEOPENTANOATEW60VYE24XCIACT
LAURYL LACTATEG5SU0BFK7OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
D&C RED NO. 7ECW0LZ41X8IACT
TOCOPHEROLR0ZB2556P8IACT
SOYBEAN OIL241ATL177AIACT
BENZOIC ACID8SKN0B0MIMIACT
POLYSILICONE-15F8DRP5BB29IACT
SUNFLOWER OIL3W1JG795YIIACT
DEHYDROACETIC ACID2KAG279R6RIACT
CRANBERRY0MVO31Q3QSIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
OLIVE OIL6UYK2W1W1EIACT
AVOCADO OIL6VNO72PFC1IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
WATER059QF0KO0RIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
SALICYLIC ACIDO414PZ4LPZIACT
SODIUM HYDROXIDE55X04QC32IIACT

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
a1115586-fb37-4c57-bddc-606dbf58a41c2bd43f78-2a3f-4072-a7e7-33e1848c6b552017-01-05WarningsExact identifier
spl id: a1115586-fb37-4c57-bddc-606dbf58a41c
spl set id: 2bd43f78-2a3f-4072-a7e7-33e1848c6b55

Reported adverse events (FAERS/openFDA)#

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