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 274 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fruit of the Earth Sun Town City Mineral SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit Of The Earth, Inc.f540b0f6-3e6c-43a7-e053-2a95a90aba742024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Mineral SPF 30 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f4481bf3-6dc7-5641-e053-2a95a90ad9382024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town CityLIP BALM SPF 30 SUNSCREEN STICKFruit of the Earth, Inc.3ec16996-ae86-4f5b-b1fd-c7b509cc5d502024-10-18WarningsExact identifier
application number: M020
Cabana Beach Club with Mentha and Essential Oils SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.f452df0c-ea8d-e25c-e053-2995a90a11432024-10-18WarningsExact identifier
application number: M020
FRUIT OF THE EARTH 100 DRY TOUCH BROAD SPECTRUM SPF 100 FACE SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEFRUIT OF THE EARTH, INC.fa18f1a9-7a6a-856e-e053-6294a90aeafa2024-10-18WarningsExact identifier
application number: M020
Cabana Beach Club with Blood Orange and Essential Oils SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.f452f94a-d2f1-60ec-e053-2995a90a88272024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Mineral SPF 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f45d25d2-9305-5858-e053-2a95a90a7f7b2024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Mineral SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit Of The Earth, Inc.f53fff7a-ef8b-19c4-e053-2a95a90a4a2a2024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth LUV THAT SUN Sport Sunscreen Continuous SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEFruit Of The Earth, Inc.fd68012d-814b-ac07-e053-6394a90afc682024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth LUV THAT SUN Sport Sunscreen Ultra SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFRUIT OF THE EARTH, INC.fd687b34-e4c6-0458-e053-6394a90ac0642024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth LUV THAT SUN Kids Sunscreen Ultra SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFRUIT OF THE EARTH, INC.fd786a06-88b7-fa35-e053-6394a90a84a52024-10-18WarningsExact identifier
application number: M020
Chemical Sunscreen SPF50 with AntipollutionHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE SUNSCREENSwiss-American CDMO, LLC59efb7dd-83f9-4222-9b7e-ea17ac4ece002024-10-18WarningsExact identifier
application number: M020
CVS Health SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyf0d6ac48-3d57-0f5c-e053-2a95a90a87cf2024-10-17WarningsExact identifier
application number: M020
CVS HEALTH SPORT SPF 50 CLEAR SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf13f7361-56b3-7ea8-e053-2995a90a76412024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 50 Ultra ProtectionAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENECVS PHARMACYf11650bb-90a0-78a1-e053-2995a90a8e4c2024-10-17WarningsExact identifier
application number: M020
CVS Health Sport SPF 70 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacyf31dd448-dc79-21f1-e053-2a95a90a7bb62024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 Breakout Free FaceAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf41478c8-76c0-727f-e053-2a95a90a86692024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 Ultra ProtectionAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf12ba764-afea-3f81-e053-2a95a90a12912024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf32ec4ef-352e-6a78-e053-2995a90af4912024-10-17WarningsExact identifier
application number: M020
CVS Health Sport SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf40e5664-e3ca-badf-e053-2a95a90a913e2024-10-17WarningsExact 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