FDA.reportPublic FDA data

SPF 50 Daily UV Defense Broad Spectrum Sunscreen

Product NDC
70484-008
11-digit product format
704840008
Labeler code
70484
Product ID
70484-008_37f244fd-c02e-e66a-e063-6394a90aed81
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Vi Medical Products, INC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-06
Substance
ZINC OXIDE; OCTINOXATE
Active strength
10.8; 7.5 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70484-00870484-008-04DDiscontinued by firm2026-10-21

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70484-00870484-008-04DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70484-00870484-008-04DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
SPF 50 Daily UV Defense Broad Spectrum Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE10.8 g/100mL
OCTINOXATE7.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d814f8a-23b5-209f-e063-6394a90a5091Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70484-008-01SPF 50 Daily UV Defense Broad Spectrum Sunscreen59 mL in 1 TUBECREAM593
70484-008-02SPF 50 Daily UV Defense Broad Spectrum Sunscreen1 in 1 CARTONCREAM13
70484-008-03SPF 50 Daily UV Defense Broad Spectrum Sunscreen30 mL in 1 TUBECREAM303
70484-008-04SPF 50 Daily UV Defense Broad Spectrum Sunscreen1 in 1 CARTONCREAM13
70484-008-05SPF 50 Daily UV Defense Broad Spectrum Sunscreen22 mL in 1 TUBECREAM223
70484-008-06SPF 50 Daily UV Defense Broad Spectrum Sunscreen1 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70484-008SPF 50 DAILY UV DEFENSE BROAD SPECTRUM SUNSCREEN (OCTINOXATE, ZINC OXIDE) CREAM [VI MEDICAL PRODUCTS, INC]2Current NDC, 6 package rows20250223_2d814f8a-23b5-209f-e063-6394a90a5091.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 71 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 421HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.ea630f2c-49a7-4900-a0ac-b0e1c554aff92026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 430HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.cc9c9b69-a0ea-44ac-a590-2cd241ce31622026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 442HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.e38a10a8-73ac-4fc5-bbde-537ccb845e6f2026-01-22WarningsExact identifier
application number: M020
Designer Lip Smoothie SPF 15 Lip BalmAVOBENZONE, OCTISALATE, HOMOSALATE, PETROLATUMAustralian Gold6fd1bd4f-ef94-42b5-a26c-2a02718c113f2026-01-22WarningsExact identifier
application number: M020
Australian Gold SPF 15 Lip BalmOCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE, PETROLEUM JELLYAustralian Gold92966c2d-b61a-4f8b-a5c1-8dfb6352c82f2026-01-22WarningsExact identifier
application number: M020
LEBELAGE UV SUN ULTRA SHIELD SUN SCREENLOTION 50gAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OCTISALATEDONGDONGGURIMOO CO.,LTD.4907eb9c-3978-27ed-e063-6394a90a9f662026-01-22WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.be9f7608-cfaa-4b16-83dd-0580047af56c2026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 15COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.6b27df44-c441-4ae8-a1b0-a9cf2fff6f212026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3c295f6b-6202-a2e1-e063-6394a90a9a602026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 19COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.b2eee48f-b644-403c-a57e-04a1491bc3862026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.ebcc2c6c-a039-48d5-8c1c-5b347254c4c22026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.6967f8bc-3092-44a9-926a-6c11676425e52026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.37d4d8c1-e76b-48a3-9a13-f0543af1b28f2026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 24WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.fa5046f2-a6db-4ac3-a78f-1b5df075d7e82026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.0c5fc63f-1899-4406-944a-1cdcdf8b42772026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.58a84ecd-3f27-40fc-8e0b-e29192679e6b2026-01-21WarningsExact identifier
application number: M020
ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE AVON COMPANY48e8b7f5-6977-bfae-e063-6394a90a888b2026-01-21WarningsExact identifier
application number: M020
Australian Gold SPF 30 Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, PETROLATUMAustralian Gold32725ca7-ec21-4643-bdc6-278fd647b95d2026-01-21WarningsExact identifier
application number: M020
Australian Gold SPF 30 Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, PETROLATUMAustralian Golde6877f7a-3aaa-4096-bcb5-eae0aa2532e52026-01-21WarningsExact identifier
application number: M020
MINICELL UV SHIELD SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECELINA CO., LTD.48eff8fa-deec-a434-e063-6294a90aa8612026-01-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70484-008-017048400080159 mL in 1 TUBE59 mlHistorical
70484-008-02704840008021 TUBE in 1 CARTON (70484-008-02) / 59 mL in 1 TUBE (70484-008-01) 1 tube2025-02-06NoNoCurrent
70484-008-037048400080330 mL in 1 TUBE30 mlHistorical
70484-008-04704840008041 in 1 CARTONHistorical
70484-008-057048400080522 mL in 1 TUBE22 mlHistorical
70484-008-06704840008061 TUBE in 1 BOX (70484-008-06) / 22 mL in 1 TUBE (70484-008-05) 1 tube2025-08-15NoNoCurrent