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 9 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Continuous Correction CreamHOMOSALATE 10% OCTISALATE 4.9% OCTOCRYLENE 4%Baxter of California, LLC14b05c8c-0398-2973-e063-6394a90a8a862026-07-31WarningsExact identifier
application number: M020
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
application number: M020
MELAO GHK-Cu PEPTIDE SUNSCREENBUTYL METHOXYDIBENZOYLMETHANE,ETHYLHEXYL SALICYLATE,HOMOSALATE,OCTOCRYLENEGuangdong Aimu Biological Technology Co., Ltd57a8c34a-d6c9-c03e-e063-6394a90a7af12026-07-29WarningsExact identifier
application number: M020
BelleJoss BROAD SPECTRUM SPF 50BROAD SPECTRUM SPF 50Guangzhou Liyan Cosmetics Technology Co., Ltd.57c07f29-2e23-d18a-e063-6394a90a10202026-07-29WarningsExact identifier
application number: M020
BemeJolie BROAD SPECTRUM SPF 50BROAD SPECTRUM SPF 50Guangzhou Liyan Cosmetics Technology Co., Ltd.57c27cea-bb0c-5d2d-e063-6394a90a1b482026-07-29WarningsExact identifier
application number: M020
DeFlameALLANTOINNoon Aesthetics M.R. Ltd2628bd73-0ca9-497b-bcd9-088444cd62be2026-07-28WarningsExact identifier
application number: M020
Native Mineral Suncare Broad Spectrum SPF 30 UnscentedZINC OXIDEThe Procter & Gamble Manufacturing Company3a89238b-d1ee-d7fa-e063-6294a90ae55f2026-07-28WarningsExact identifier
application number: M020
First Aid Beauty FAB Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Companydfb1b42e-c821-1a41-e053-2995a90acf952026-07-28WarningsExact identifier
application number: M020
HEB 50 Pumpkin Spice Latte Scent SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B.579f3274-398e-7eab-e063-6394a90afe352026-07-27WarningsExact identifier
application number: M020
LUXE COLOR FOUNDATIONOCTINOXATE 7% ZINC OXIDE 5%Guangzhou Huixue Biotechnology Co., Ltd.576c3496-702f-808c-e063-6394a90a53c32026-07-25WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25 KitAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEXact Packing Limited5759058d-e683-f3fc-e063-6394a90abc012026-07-24WarningsExact identifier
application number: M020
No7 Future Renew Defense Shield SPF 50AVOBENZONE, OCTINOXATE, OCTISALATEXact Packing Limited5758b79f-6386-bbea-e063-6394a90aeb342026-07-24WarningsExact identifier
application number: M020
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
application number: M020
SERVE AND PRIME SUNSCREEN BROAD SPECTRUM SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEESTEE LAUDER INC575fc04a-794a-93e7-e063-6394a90a7e672026-07-24WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHTZINC OXIDEYounique, LLCf93d42a9-b655-4b75-a16d-b29f38f04efc2026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHT MEDIUMZINC OXIDEYounique, LLC82769819-b229-4864-9b3c-44f49a68a53a2026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIRZINC OXIDEYounique, LLCed700cae-8226-48d9-93ba-03154aa1cae52026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIR LIGHTZINC OXIDEYounique, LLCd728b89c-692f-485b-88c3-929b2f0350d52026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUMZINC OXIDEYounique, LLCa49dfff1-e9ec-4573-90b0-ef6a7226aa562026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUM DARKZINC OXIDEYounique, LLCcc576b63-caf4-491d-8d7f-027b1127133b2026-07-23WarningsExact 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