FDA.reportPublic FDA data

Bright Guard Sport SPF

Product NDC
76348-675
11-digit product format
763480675
Labeler code
76348
Product ID
76348-675_34f59c89-eb97-6c31-e063-6394a90ab07f
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC SPF
Dosage form
LOTION
Route
TOPICAL
Labeler
RENU LABORATORIES, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-01
Substance
ZINC OXIDE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
Active strength
17.5; 70; 10; 12.5 g/1000g; g/1000g; g/1000g; g/1000g
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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76348-675-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76348-675-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76348-675-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76348-675-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76348-675-01UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76348-675-01UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76348-675-01UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
Bright Guard Sport SPF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE17.5 g/1000g
OCTINOXATE70 g/1000g
OCTISALATE10 g/1000g
TITANIUM DIOXIDE12.5 g/1000g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c9b48a9e-d69f-65a7-e053-2995a90a0bafAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-675-012025-05-12C16284748780-12cef2736-621a-d83d-e063-dadaa90ab31fBright Guard Sport SPF 30
76348-675-012025-01-30C16284748780-12cef2736-621a-d83d-e063-dadaa90ab31fBright Guard Sport SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-675-01Bright Guard Sport SPF1000 g in 1 POUCHLOTION10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-675BRIGHT GUARD SPORT SPF (ZINC SPF) LOTION [RENU LABORATORIES, LLC]2Current NDC, Legacy NDC, 1 package rows20250514_c9b48a9e-d69f-65a7-e053-2995a90a0baf.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 162 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF 25 LIP BALMAVOBENZONE, OCTISALATE, HOMOSALATEDrmtlgy, LLC8aed2fb0-f7b8-4ff0-b597-144c0557789e2025-11-18WarningsExact identifier
application number: M020
Sunny Defense Sunscreen StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd262450f0-c4a1-dcca-e063-6394a90ae3cd2025-11-17WarningsExact identifier
application number: M020
Tone Blur Essence SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd1814b5e7-5bbf-df16-e063-6294a90a96c42025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 17NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c48c66-bd5b-0024-e063-6394a90a6c7b2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 19COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c512da-e4b6-dd9c-e063-6294a90a17302025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c52258-2549-c42b-e063-6394a90a15262025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c59de6-8eb2-d00a-e063-6294a90a0b042025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 24WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c5bd02-62e0-019a-e063-6294a90adcf32025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 23WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c5d54e-119c-0c6d-e063-6394a90aba4c2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 25NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c5eb1c-b268-acfb-e063-6394a90ad4cc2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 27COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c6157a-4b62-8279-e063-6294a90abe052025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 27WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c6252f-56b8-9e3c-e063-6294a90aa12c2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 28NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c62e80-9ace-c1f2-e063-6294a90a5bfa2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 29WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c6864c-bc8e-e900-e063-6294a90a7a142025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 31NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c77b48-18fb-3efe-e063-6294a90ade4b2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 33NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c784ce-3a54-5416-e063-6294a90ac9a22025-11-17WarningsExact identifier
application number: M020
Daily Essential Face MoisturizerZINC OXIDESolarium Brands LLC2a92edc1-04ac-3eda-e063-6294a90ad46d2025-11-17WarningsExact identifier
application number: M020
Daily Essential Eye CreamTITANIUM DIOXIDE, ZINC OXIDESolarium Brands LLC2a931d9f-4ba8-e3a5-e063-6294a90af7802025-11-17WarningsExact identifier
application number: M020
Daily Essential Lip Oil Blushing NudeZINC OXIDESolarium Brands LLC2a93998c-185b-9207-e063-6294a90ab0e92025-11-17WarningsExact identifier
application number: M020
Solarium Daily Essentials Skin Perfecting PrimerZINC OXIDESolarium Brands LLC302a02d1-3dc5-2745-e063-6394a90ab6d22025-11-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76348-675-01763480675011000 g in 1 POUCH (76348-675-01) 1000 g2021-07-010000-00-00NoNoCurrent