Broad Spectrum Moisturizing Sunscreen SPF 30

Product NDC
70367-005
Requested package NDC
70367-005-04
11-digit product format
703670005
Labeler code
70367
Product ID
70367-005_9cd57085-9029-9388-e053-2995a90a2600
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Zinc Oxide, Octisalate, Oxybenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Only Yourx, Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-08-26
Marketing end
0000-00-00
Substance
OCTINOXATE; ZINC OXIDE; OCTISALATE; OXYBENZONE
Active strength
7 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage70367-00570367-005-04IInactivated by FDA2026-10-16

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 · 16 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70367-005-012022-07-29C16284748780-1e4f33bdf-9dd0-d8a0-e053-dadaa90a6e4e74b061aa-7292-f41d-e053-2a91aa0a190b
70367-005-042022-07-29C16284748780-1e4f33bdf-9dd0-d8a0-e053-dadaa90a6e4e74b061aa-7292-f41d-e053-2a91aa0a190b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70367-005-01Broad Spectrum Moisturizing Sunscreen SPF 3030 mL in 1 TUBELOTION303
70367-005-04Broad Spectrum Moisturizing Sunscreen SPF 30120 mL in 1 TUBELOTION1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70367-005BROAD SPECTRUM MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE) LOTION [ONLY YOURX, INC.]3Legacy NDC, 2 package rows20200124_74b061aa-7292-f41d-e053-2a91aa0a190b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70367-005-0470367000504120 mL in 1 TUBE (70367-005-04) 120 ml2014-08-260000-00-00NoNoCurrent