FDA.reportPublic FDA data

Shimmer Oil

Product NDC
80641-015
11-digit product format
806410015
Labeler code
80641
Product ID
80641-015_3313a906-cb44-a2a7-e063-6394a90a1b22
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone Homosalate Octisalate Octocrylene
Dosage form
OIL
Route
TOPICAL
Labeler
Vacation Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-07
Substance
AVOBENZONE; OCTOCRYLENE; OCTISALATE; HOMOSALATE
Active strength
2.9; 8; 4.9; 5 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Shimmer Oil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE2.9 g/100mL
OCTOCRYLENE8 g/100mL
OCTISALATE4.9 g/100mL
HOMOSALATE5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
V06SV4M95SInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
131c63ba-57fc-9ce8-e063-6294a90acd92Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-015-02Shimmer Oil1 in 1 KITOIL14
80641-015-15Shimmer Oil86 mL in 1 BOTTLEOIL864
80641-015-15Vacation by Vacation Scent and Shimmer Duo86 mL in 1 BOTTLEOIL86 mL8 g in 100mL3
80641-015-15Vacation by Vacation Scent and Shimmer Duo86 mL in 1 BOTTLEOIL86 mL2.9 g in 100mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80641-015SHIMMER OIL (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE) OIL [VACATION INC.]4Current NDC, 2 package rows20250420_131c63ba-57fc-9ce8-e063-6294a90acd92.zip
80641-015VACATION BY VACATION SCENT AND SHIMMER DUO (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) KIT [VACATION INC.]3Current NDC20240601_aef8388f-84bb-4e2b-8ae2-aa64f415a632.zip

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 171 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Reef Babies SPF 50 Oxybenzone FreeOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.d5ed3488-aa32-4a63-9996-12c6532c3a4d2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b559499c-6109-bf5e-e053-2995a90a4ac72025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 50OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e24ca1-d041-355d-e053-2995a90a3d612025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5570cbd-89f5-65d5-e053-2995a90a54d12025-11-04WarningsExact identifier
application number: M020
Land Shark Zinky SPF 36 Azure BlueZINC OXIDETropical Seas, Inc.d23fe61a-3ffb-59d0-e053-2995a90a59e62025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b55a0bd0-2a32-2977-e053-2a95a90aa1422025-11-04WarningsExact identifier
application number: M020
Expedition BackCountry SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.06d43525-86d8-f2d9-e063-6394a90afc812025-11-04WarningsExact identifier
application number: M020
Land Shark Zinky SPF 36 Pacific PurpleZINC OXIDETropical Seas, Inc.d240fe7c-9d16-78c9-e053-2a95a90a763c2025-11-04WarningsExact identifier
application number: M020
Expedition BackCountry SPF 50OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.06c1ac52-474c-db5c-e063-6294a90afb5f2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30 Tinted ZincZINC OXIDE AND TITANIUM DIOXIDETropical Seas, Inc.d1287899-f178-6124-e053-2a95a90a95a52025-11-04WarningsExact identifier
application number: M020
Naked Sundays BeautyScreen Peptide Foundation TintZINC OXIDENaked Sundays1a623dfc-a8fc-858b-e063-6294a90a9c112025-11-04WarningsExact identifier
application number: M020
Odacite Mineral Drops Sheer SunscreenZINC OXIDEOdacite303f3af6-631a-57a8-e063-6294a90addda2025-11-04WarningsExact identifier
application number: M020
MedlineZINC OXIDEMedline Industries, LPcadba3bc-4a06-872a-e053-2995a90ab4472025-11-04WarningsExact identifier
application number: M020
Perricone MD Hypoallergenic CBD Sensitive Skin Therapy Ultra-Lightweight Calming SPF 35 VeilZINC OXIDETHG Beauty USA LLC2392c772-c251-1597-e063-6394a90a52f22025-11-03WarningsExact identifier
application number: M020
Hawaiian Tropic everyday Active Sport Sunscreen SPF50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care LLCdc7d0757-c8a2-7fdb-e053-2a95a90a52822025-11-03WarningsExact identifier
application number: M020
MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant (80min) Mineral Sunscreen LIGHTTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesa7f906f6-3041-4c24-955d-90cdd402dd022025-11-03WarningsExact identifier
application number: M020
Biopo Facial Mineral Sunscreen-Non Tinted SPF 40BIOPO FACIAL MINERAL SUNSCREEN-NON TINTED SPF 40Guangzhou Ariel Biotech Co., Ltd.42bc865f-29bd-da90-e063-6294a90aa16d2025-11-03WarningsExact identifier
application number: M020
Biopo Facial Mineral Sunscreen- Tinted SPF 40BIOPO FACIAL MINERAL SUNSCREEN- TINTED SPF 40Guangzhou Ariel Biotech Co., Ltd.42bd8bce-2959-266a-e063-6394a90a9a412025-11-03WarningsExact identifier
application number: M020
GoodSense SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Geiss, Destin, & Dunn, Inc.c23c754a-9441-0a05-e053-2995a90afc552025-11-02WarningsExact identifier
application number: M020
SPF 30 Sport Sunscreen GoodSenseAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8%Geiss, Destin, & Dunn, Inca22c6359-435d-626b-e053-2a95a90ae0c62025-11-02WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80641-015-02806410015021 BOTTLE in 1 KIT (80641-015-02) / 86 mL in 1 BOTTLE (80641-015-15) 1 bottle2025-04-18NoNoCurrent
80641-015-158064100151586 mL in 1 BOTTLE (80641-015-15) 86 ml2024-03-07NoNoCurrent