Per Sole by Britto Lip Balm Sunscreen Broad Spectrum SPF 30

Product NDC
77069-001
Requested package NDC
77069-001-01
11-digit product format
770690001
Labeler code
77069
Product ID
77069-001_b77c5d6c-aa65-32f1-e053-2995a90abd7c
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octinoxate, Octocrylene
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
MR2 USA Corporation
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-07-23
Marketing end
0000-00-00
Substance
OCTINOXATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE
Active strength
8 g/100g; g/100g; g/100g; g/100g
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 packagepackage77069-00177069-001-01IInactivated by FDA2026-10-05

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 · 18 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…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
77069-001-012022-01-28C16284748780-1d6a99b39-8188-a426-e053-dadaa90af4c2NO CHANGE NOTIFICATION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77069-001-01Per Sole by Britto Lip Balm Sunscreen Broad Spectrum SPF 303.5 g in 1 CYLINDERLIPSTICK3.52
77069-001-01Per Sole by Britto Lip Balm Sunscreen Broad Spectrum SPF 303 in 1 BLISTER PACKLIPSTICK32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77069-001PER SOLE BY BRITTO LIP BALM SUNSCREEN BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE) LIPSTICK [MR2 USA CORPORATION]2Legacy NDC, 2 package rows20201228_a9f25fca-0f4f-c46b-e053-2995a90afa91.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77069-001-01770690001013 CYLINDER in 1 BLISTER PACK (77069-001-01) > 3.5 g in 1 CYLINDER3 cylinder2020-07-230000-00-00NoNoCurrent