BIRDS GARDEN LIP BALM

Product NDC
75862-009
11-digit product format
758620009
Labeler code
75862
Product ID
75862-009_3ebba235-a0a8-4f0d-bd1a-44529a6229bf
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE
Dosage form
STICK
Route
TOPICAL
Labeler
GANZ U.S.A., LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-01-01
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE
Active strength
8 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct75862-009IInactivated by FDA2026-10-05
excluded packagepackage75862-00975862-009-50IInactivated 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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage75862-009-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage75862-009-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage75862-009-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage75862-009-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage75862-009-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage75862-009-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage75862-009-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage75862-009-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage75862-009-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage75862-009-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage75862-009-50367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage75862-009-50557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage75862-009-508af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage75862-009-50834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage75862-009-501332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage75862-009-50fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage75862-009-5086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage75862-009-50bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage75862-009-508dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage75862-009-50e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage75862-009-509bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage75862-009-50110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75862-009-502019-10-29C16284748780-1960f7f55-c800-8e05-e053-dbdaa90a074aLIP BALM ALOE & VITAMIN E UVA / UVB PROTECTION SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75862-009-50BIRDS GARDEN LIP BALM CERULEAN WARBLER SPF 304 g in 1 TUBESTICK41

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51BIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51BIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
OCTISALATEACTIVE MOIETY4X49Y0596WBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0BIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19BIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
LANOLININACTIVE INGREDIENT7EV65EAW6HBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
LOW DENSITY POLYETHYLENEINACTIVE INGREDIENTJ245LN42AIBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
OLEYL ALCOHOLINACTIVE INGREDIENT172F2WN8DVBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4RBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
SACCHARININACTIVE INGREDIENTFST467XS7DBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
SOYBEAN OILINACTIVE INGREDIENT241ATL177ABIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75862-009BIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [GANZ U.S.A., LLC]1Legacy NDC, 1 package rows20110103_4e42fbd0-c343-41b0-bbbe-0f82567470c8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
75862-009-50758620009504 g in 1 TUBE4 gHistorical