FDA.reportPublic FDA data

Surf Bay Lip Balm

Manufacturer
Universal Packaging Systems, Inc. DBA: PakLab
Effective date
2015-09-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:44:02

Label at a glance#

ProductSurf Bay Lip Balm
Active ingredientOCTINOXATE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

OTC - PURPOSE SECTION

Help protect again sunburn and chapped lips

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warnings: Keep out of reach of children

INSTRUCTIONS FOR USE SECTION

Apply liberaly 15 minutes before sun exposure

INACTIVE INGREDIENT SECTION

Hydrogenated Soybean Oil, Butyrospermum Parkii (Shea) Butter, Beeswax (CERA ALBA), Limnanthes Alba (Meadowfoam) Seed Oil, C10-18 Triglycerides, Hydrogenated Soy Polyglycerides, Flavor (Aroma), Propylene Glycol Myristyl Ether Acetate, Lauryl Lactate, Mentha Piperita (Peppermint) Oil, Salicylic Acid, Tocopheryl Acetate, C15-23 Alkane,

Sclerocarya Birrea Seed Oil, Triticum Vulgare (Wheat) Germ Oil, Cinnamal, Sucralose, Myristyl Alcohol, Propylene Glycol, Acetic Acid.

OTC - QUESTIONS SECTION

Questions or Comments? 702-347-1229 or email info@baysoleil.com

WARNINGS SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

Helps protect against sunburn and chapped lips

DOSAGE & ADMINISTRATION SECTION

Topical gel

Surfbay Display panel jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Surfbay Display panel jpgSurfbay Display panel jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61531-100-012020-01-31C16284748780-19d75b9d0-8056-f424-e053-dadaa90a57ce2096ffe7-27eb-244f-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61531-100-01Surf Bay Lip Balm15 g in 1 TUBEGEL151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61531-100SURF BAY LIP BALM (LIP BALM) GEL [UNIVERSAL PACKAGING SYSTEMS, INC. DBA: PAKLAB]1Legacy NDC, 1 package rows20151112_2096ffe7-27eb-244f-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61531-10061531-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates

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
2096ffe7-27ec-244f-e054-00144ff8d46c2096ffe7-27eb-244f-e054-00144ff8d46c2015-09-25WarningsExact identifier
spl id: 2096ffe7-27ec-244f-e054-00144ff8d46c
spl set id: 2096ffe7-27eb-244f-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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