FDA.reportPublic FDA data

Sunscreen SPF 30

Product NDC
80524-002
11-digit product format
805240002
Labeler code
80524
Product ID
80524-002_2b321485-0ffa-4d50-e063-6394a90a9c18
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Dosage form
LOTION
Route
TOPICAL
Labeler
Tempo Industries, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-18
Substance
AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength
30; 100; 100; 50 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage80524-002-53fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage80524-002-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage80524-002-5386f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage80524-002-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage80524-002-53bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage80524-002-30bd6a592717d7…303034d00443…

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
Sunscreen SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE100 mg/mL
OCTOCRYLENE100 mg/mL
OCTISALATE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
af9aa56d-2f8a-55b9-e053-2a95a90a3258Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
80524-002-302023-12-15Sunscreen SPF 30
80524-002-532023-12-15Sunscreen SPF 30
80524-002-302022-01-28Sunscreen SPF 30
80524-002-532022-01-28Sunscreen SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80524-002-30Sunscreen SPF 3030 mL in 1 BOTTLELOTION303
80524-002-53Sunscreen SPF 3053 mL in 1 BOTTLELOTION533

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80524-002SUNSCREEN SPF 30 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) LOTION [TEMPO INDUSTRIES, INC.]3Current NDC, Legacy NDC, 2 package rows20250110_af9aa56d-2f8a-55b9-e053-2a95a90a3258.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 50 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ULTRALIGHT AGE DEFENSE SPF 50ZINC OXIDEGuangzhou Origin Beauty Cosmetics Co., Ltd.4e36a743-7906-2b7b-e063-6294a90af3142026-03-29WarningsExact identifier
application number: M020
Stay Put Sunscreen SPF 30OCTINOXATE 7.50% OCTISALATE 5.00% OXYBENZONE 4.00% HOMOSALATE 10.00%Sawyer Products Inc7ecba495-a912-4697-8287-2e5836e610e12026-03-27WarningsExact identifier
application number: M020
UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS DARK SHADETITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLC4e0bd355-99c6-8cf4-e063-6294a90ab4b32026-03-27WarningsExact identifier
application number: M020
Vacation X AZ Lemon Tea Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.61c48acc-f589-40d3-b289-b777db5551db2026-03-27WarningsExact identifier
application number: M020
Truly Solar Baby Suncreen SPF 45HOMOSALATE 15% OCTISALATE 5% OCTOCRYLENE 10% AVOBENZONE 3%Truly Beauty, Inc38e6c6fc-d8b9-4196-96c7-0f6d5d06da022026-03-26WarningsExact identifier
application number: M020
burndHOMOSALATE, OCTINOXATE, ZINC OXIDEBURND LLC31cf923e-fdde-790b-e063-6294a90a60ee2026-03-26WarningsExact identifier
application number: M020
SUNNYSIDEKICK UVA/UVB Broad Spectrum SPF 30 Brush-On MineralZINC OXIDE, TITANIUM DIOXIDEClassic Cosmetics LLC4df3b8c0-71bc-acdd-e063-6394a90a35c02026-03-26WarningsExact identifier
application number: M020
COSRXVITAMIN E VITALIZING SUNSCREENCOSRX inc.4df77564-9da0-7e48-e063-6294a90a5e6b2026-03-26WarningsExact identifier
application number: M020
Mentholatum Natural Ice Protect Plus SPF 30 Protect Plus SPF 30AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company3804a14b-be7c-a973-e063-6294a90ac7fc2026-03-25WarningsExact identifier
application number: M020
Softlips Oasis Pineapple CoconutDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Companyc504463a-28bf-4161-875f-ef73520931c52026-03-25WarningsExact identifier
application number: M020
Mentholatum Natural Ice Cherry, SPF 15 CherryDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company37f2c3a6-7790-c8ec-e063-6294a90ace222026-03-25WarningsExact identifier
application number: M020
Mentholatum Natural Ice - Original, SPF 15 OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company37dc44aa-17b2-8721-e063-6294a90a34f62026-03-25WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.0ef5d5ce-3bdf-dffc-e063-6394a90aad542026-03-25WarningsExact identifier
application number: M020
Silkscreen Sheer Tint Mineral Light-MediumTITANIUM DIOXIDE, ZINC OXIDECurology4ddbe349-6880-a5fc-e063-6294a90a275c2026-03-25WarningsExact identifier
application number: M020
AXIS-Y Complete No-Stress Physical Sunscreen V.3ZINC OXIDEAsia Master Trade Co.,Ltd1f310fb1-185a-b467-e063-6294a90a72fe2026-03-25WarningsExact identifier
application number: M020
BANANA BOATTITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLC4e0450ca-147a-91d7-e063-6394a90ae73b2026-03-25WarningsExact identifier
application number: M020
Mentholatum Natural Ice OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company29220eaa-87cb-4ebe-87db-d36288b3a9e42026-03-24WarningsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLCf54c617f-794e-413b-b898-4a06622b4bee2026-03-24Warnings, Adverse reactionsExact identifier
application number: M020
VITAL PERFECTION UPLIFTING AND FIRMING ADVANCED DAYAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENEShiseido Americas Corporation7b2d15c1-b9e1-4347-b138-9883f78822b32026-03-24WarningsExact identifier
application number: M020
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.4dd05620-30a3-9cea-e063-6294a90af18b2026-03-24WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80524-002-308052400023030 mL in 1 BOTTLE (80524-002-30) 30 ml2020-09-180000-00-00NoNoCurrent
80524-002-538052400025353 mL in 1 BOTTLE (80524-002-53) 53 ml2020-09-180000-00-00NoNoCurrent