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
2027-12-31
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
2027-12-31

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 319 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rosehip and Lemongrass Lip SPF 15ZINC OXIDEEminence Organic Skin Care4354171a-fd25-4c56-a67c-d48194ea98902023-11-30WarningsExact identifier
application number: M020
SOOTHE Daily Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERodan & Fields9acbf663-15e4-4572-a267-56afa58a347b2023-11-30WarningsExact identifier
application number: M020
EltaMD UV Facial SPF30 PlusZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health Group, Inc.8426b0a0-ecd6-4486-b2da-57a950b46dc52023-11-30WarningsExact identifier
application number: M020
Eminence Bright Skin Starter Set KitZINC OXIDEEminence Organic Skin Care6335dfaf-ebdf-4b7b-999e-fabeeaa907ed2023-11-29WarningsExact identifier
application number: M020
Cetaphil Healthy Radiance Whipped Day Cream Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.69cdf676-34f6-4864-a2a6-9f547b0b45a02023-11-28WarningsExact identifier
application number: M020
Walgreens SPF 30 Premium Moisturizing Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY0b24d878-065b-008c-e063-6394a90aa2cf2023-11-27WarningsExact identifier
application number: M020
UNBLEMISH Invisible Matte DefenseHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONERodan & Fields9dfe7d50-f347-4671-9657-5e4fbe42b4412023-11-27WarningsExact identifier
application number: M020
SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDerma Care Research Labs, LLC0aacafca-baf7-9a22-e063-6394a90a2ca92023-11-21WarningsExact identifier
application number: M020
SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDerma Care Research Labs, LLC0aad5ced-f356-e294-e063-6394a90aa8d52023-11-21WarningsExact identifier
application number: M020
SPF 60 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDerma Care Research Labs, LLC0aae69f1-66bf-a199-e063-6394a90a3d752023-11-21WarningsExact identifier
application number: M020
Walgreens SPF 30 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY0aaeaf00-a438-8164-e063-6394a90a88362023-11-21WarningsExact identifier
application number: M020
Walgreens SPF 50 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY0ab169df-a760-8978-e063-6394a90ac2f42023-11-21WarningsExact identifier
application number: M020
Sun X SPF 50 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMCoreTex Products, INCc0355990-b842-47cd-e053-2a95a90a7c822023-11-20WarningsExact identifier
application number: M020
SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDerma Care Research Labs, LLC0a9b61ac-4f48-8399-e063-6394a90a43fe2023-11-20WarningsExact identifier
application number: M020
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDERite Aid0a9c1b3f-656d-0d62-e063-6394a90a47312023-11-20WarningsExact identifier
application number: M020
Rite Aid Mineral Zinc Oxide Sunscreen Broad Spectrum SPF 50ZINC OXIDERite Aid0a9c37b1-6df3-37c6-e063-6394a90ac8c32023-11-20WarningsExact identifier
application number: M020
SPF 15 Lip and SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.0b385246-dc77-6874-e063-6394a90a59592023-11-20WarningsExact identifier
application number: M020
Cetaphil Sheer Mineral Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.581e8289-1406-45b6-9786-753800665fad2023-11-20WarningsExact identifier
application number: M020
Alba Botanica Maximum Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHain Celestial Group, Inc02ba8b03-a1fc-608f-e063-6394a90a06a82023-11-16WarningsExact identifier
application number: M020
Alba Botanica Hawaiian SPF 50 CoconutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHain Celestial Group, Incf693699d-716c-af7f-e053-2a95a90af11a2023-11-16WarningsExact 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