BALANCE DYNAMICS BALANCING

Product NDC
68828-150
11-digit product format
688280150
Labeler code
68828
Product ID
68828-150_3a483673-b894-4efe-9021-5c10cdd637ee
Type
HUMAN OTC DRUG
Nonproprietary name
OCTISALATE OXYBENZONE OCTINOXATE
Dosage form
LOTION
Route
TOPICAL
Labeler
JAFRA COSMETICS INTERNATIONAL
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-04-24
Marketing end
0000-00-00
Substance
OCTISALATE; OXYBENZONE; OCTINOXATE
Active strength
4 g/100mL; g/100mL; g/100mL
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68828-150IInactivated by FDA2026-10-16
excluded packagepackage68828-15068828-150-12IInactivated by FDA2026-10-16
excluded packagepackage68828-15068828-150-17IInactivated 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 2 · 66 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 packagepackage68828-150-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68828-150-17d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68828-150-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68828-150-17f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68828-150-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68828-150-172ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68828-150-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68828-150-17a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68828-150-12cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68828-150-17cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68828-150-12cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68828-150-17cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68828-150-12302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68828-150-17302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68828-150-12ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68828-150-17ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68828-150-120efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68828-150-170efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68828-150-12ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68828-150-17ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68828-150-12367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68828-150-17367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68828-150-12557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68828-150-17557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68828-150-128af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68828-150-178af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68828-150-12834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68828-150-17834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68828-150-121332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68828-150-171332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68828-150-17fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68828-150-12fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68828-150-1786f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68828-150-1286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68828-150-17bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68828-150-12bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68828-150-178dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68828-150-128dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68828-150-17e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68828-150-12e2bbac7714bc…27bdfed8d636…

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68828-150-122020-01-31C16284748780-19d75b9d0-037c-f424-e053-dadaa90a57ceBALANCE DYNAMICS BALANCING LOTION SPF-15
68828-150-172020-01-31C16284748780-19d75b9d0-037c-f424-e053-dadaa90a57ceBALANCE DYNAMICS BALANCING LOTION SPF-15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-150-12BALANCE DYNAMICS BALANCINGSPF 151 in 1 BOXLOTION11
68828-150-17BALANCE DYNAMICS BALANCINGSPF 157 mL in 1 TUBELOTION71
68828-150-62BALANCE DYNAMICS BALANCINGSPF 1550 mL in 1 BOTTLELOTION501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
OCTISALATEACTIVE MOIETY4X49Y0596WBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
BIOSACCHARIDE GUM-1INACTIVE INGREDIENTBB4PU4V09HBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RABALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
CENTELLA ASIATICA LEAFINACTIVE INGREDIENT6810070TYDBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
CHONDRUS CRISPUSINACTIVE INGREDIENTOQS23HUA1XBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
DIGLYCERININACTIVE INGREDIENT3YC120743UBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MBBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
GINGERINACTIVE INGREDIENTC5529G5JPQBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
IPOMOEA MAURITIANA TUBERINACTIVE INGREDIENTK67Y2SGX79BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
IRIS GERMANICA VAR. FLORENTINA ROOTINACTIVE INGREDIENTM30XO5X4XDBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
SACCHARINA LATISSIMA THALLUSINACTIVE INGREDIENT68CMP2MB55BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
SILANETRIOLINACTIVE INGREDIENTE52D0J3TS5BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
TRIBEHENIN PEG-20 ESTERSINACTIVE INGREDIENT84K9EH29Y9BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
WATERINACTIVE INGREDIENT059QF0KO0RBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
WITHANIA SOMNIFERA FLOWERINACTIVE INGREDIENT2HZ95R7082BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
XYLITYLGLUCOSIDEINACTIVE INGREDIENTO0IEZ166FBBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
ZINC SULFATEINACTIVE INGREDIENT89DS0H96TBBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-150BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1Legacy NDC, 3 package rows20120601_31066ffd-d8be-4390-bc91-268162945de9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68828-150-12688280150121 in 1 BOXHistorical
68828-150-17688280150177 mL in 1 TUBE7 mlHistorical
68828-150-626882801506250 mL in 1 BOTTLE50 mlHistorical