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 66 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zealios Mineral SPF 30 SunscreenZINC OXIDEPersonal Best Products Inc. dba Zealiosc421b00c-6536-4455-81f6-01686f8c23882026-02-03WarningsExact identifier
application number: M020
Zealios Sport Performance Ultralight SPF 50 SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEPersonal Best Products Inc. dba Zealios020bd1b4-da50-4117-a4f3-b74aa41873962026-02-03WarningsExact identifier
application number: M020
Adrien Arpel Daily Defense Moisturizer SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEColor Me Beautiful Incf65e1428-b79a-4126-862a-907ca17ee8f72026-02-02WarningsExact identifier
application number: M020
Flori Roberts Daily Defense Moisturizer SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEColor Me Beautiful Inc934d6b80-0cc3-4dcd-a25d-2191bd2736182026-02-02WarningsExact identifier
application number: M020
Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREENHOMOSALATE, OCTYL SALICYLATE, TITANIUM DIOXIDE, ZINC OXIDEOracle Cosmetic Co., Ltd.21424f78-f8d5-6a9b-e063-6294a90ab7dc2026-02-02WarningsExact identifier
application number: M020
HAMPTON SUN SPF50 SUNSHIELD BODY GLOWHOMOSALATE 10% OCTOCRYLENE 10% AVOBENZONE 3% OCTICALATE 5%S&C Hampton Sun LLC26190992-9463-47ae-86a5-0dbc05be87732026-02-02WarningsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENERite Aid Corporationfe9146ec-b85d-43da-a391-377960f2c7722026-02-02Warnings, Adverse reactionsExact identifier
application number: M020
sheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERite Aid Corporation299a6690-9746-4410-a625-7636f0b4a7542026-02-02Warnings, Adverse reactionsExact identifier
application number: M020
Dr. C. Tuna Sun Stick SPF 50AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENEFarmasi US LLC49dc6040-b400-7f5b-e063-6394a90ac7d72026-02-02WarningsExact identifier
application number: M020
Naturium Dew Glow Moisturizer Mineral SPF 50ZINC OXIDEe.l.f. Cosmetics, Inc535f798f-d21d-92b2-e063-6294a90a72c72026-02-02WarningsExact identifier
application number: M020
Sol de Janiero Rio Radiance SPF 50 BodyZINC OXIDECosmetic Solutions LLC2d54727d-5dcc-4792-85e8-1a2f21fe9e3d2026-02-02WarningsExact identifier
application number: M020
Sky and Sol Face and Body Sunscreen Spf 50ZINC OXIDEDelta Ecommerce LLC47d9dc66-328f-4cab-e063-6394a90a279d2026-02-01WarningsExact identifier
application number: M020
e.l.f. Suntouchable Invisi-Stick Glitz SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f cosmetics,Inc.4b801bb3-8930-7e04-e063-6294a90adaa12026-02-01WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR CLEARAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationcedd7a3e-3334-437f-a283-482bcd0064ee2026-01-30WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationbf16e8b5-b717-4255-a7da-9abe3d1ad8b42026-01-30WarningsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERite Aid Corporation372a8fba-b190-40fe-a1fc-fecf7f7afc352026-01-30Warnings, Adverse reactionsExact identifier
application number: M020
ALOE UP MEDICATED LIP BALM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEAloe Care International, LLC859b6d3f-b1ca-4966-8f0c-f9afa0d5864c2026-01-30WarningsExact identifier
application number: M020
ALOE UP SPORT NATURAL BALM SPF-15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC3de029ed-97f7-4cb3-a32e-d412bf3b58742026-01-30WarningsExact identifier
application number: M020
Reef safe unscented SPF 50 mineral sunscreen 01TITANIUM DIOXIDE, ZINC OXIDECosmuses Cosmetics (Ningbo) Co., Ltd.49a77ad4-508c-9617-e063-6394a90a56232026-01-30WarningsExact identifier
application number: M020
JOSIE MARAN ARGAN SUN MILK MINERAL SUNSCREEN BROAD SPECTRUM SPF 33TITANIUM DIOXIDE AND ZINC OXIDECosmetic Solutions LLCd65ae1c9-dff5-4612-b8be-fa59bba03b812026-01-30WarningsExact 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