LBEL

Product NDC
14783-121
11-digit product format
147830121
Labeler code
14783
Product ID
14783-121_652ed997-a464-4c52-870e-28c8bf3e3083
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate and Oxybenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Ventura International Ltd. (San Juan, P.R)
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-11-14
Marketing end
0000-00-00
Substance
OCTINOXATE; OXYBENZONE
Active strength
0 mL/mL; mL/mL
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 productproduct14783-121DDiscontinued by firm2026-10-05
excluded packagepackage14783-12114783-121-01DDiscontinued by firm2026-10-05

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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage14783-121-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage14783-121-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage14783-121-01IInactivated 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 packagepackage14783-121-01IInactivated 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 packagepackage14783-121-01IInactivated 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 packagepackage14783-121-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage14783-121-01IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage14783-121-01IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage14783-121-01IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage14783-121-01IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage14783-121-01IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage14783-121-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage14783-121-01IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage14783-121-01IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage14783-121-01IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage14783-121-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage14783-121-01IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage14783-121-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage14783-121-01IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage14783-121-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage14783-121-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage14783-121-01IInactivated by FDA110d247fa046…a55b01930146…

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
14783-121-012025-05-21C16284748780-197449f38-cf3b-f6ea-e053-dbdaa90aa703DIVINE LIP GLOSS
14783-121-012019-11-13C16284748780-197449f38-cf3b-f6ea-e053-dbdaa90aa703DIVINE LIP GLOSS

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD51LBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
OxybenzoneACTIVE INGREDIENT95OOS7VE0YLBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
OctinoxateACTIVE MOIETY4Y5P7MUD51LBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
OxybenzoneACTIVE MOIETY95OOS7VE0YLBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
almond oilINACTIVE INGREDIENT66YXD4DKO9LBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XLBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
alpha-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L0LBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
aluminum oxideINACTIVE INGREDIENTLMI26O6933LBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KLBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
cochinealINACTIVE INGREDIENTTZ8Z31B35MLBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
coconut oilINACTIVE INGREDIENTQ9L0O73W7LLBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
D&C red no. 7INACTIVE INGREDIENTECW0LZ41X8LBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
diisopropyl dilinoleateINACTIVE INGREDIENT5323S7S2LRLBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBDLBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOALBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
FD&C yellow no. 5INACTIVE INGREDIENTI753WB2F1MLBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
ferric oxide redINACTIVE INGREDIENT1K09F3G675LBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTLBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357LBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXLBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
isostearyl neopentanoateINACTIVE INGREDIENT411THY156QLBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
lemon oilINACTIVE INGREDIENTI9GRO824LLLBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
lemon peel waxINACTIVE INGREDIENT20G0UPO0TILBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TLBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
micaINACTIVE INGREDIENTV8A1AW0880LBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
orange oilINACTIVE INGREDIENTAKN3KSD11BLBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
orange peel waxINACTIVE INGREDIENT0U715N387CLBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
palmitic acidINACTIVE INGREDIENT2V16EO95H1LBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHLBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYLBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
silica dimethyl silylateINACTIVE INGREDIENTEU2PSP0G0WLBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
talcINACTIVE INGREDIENT7SEV7J4R1ULBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2
yellow waxINACTIVE INGREDIENT2ZA36H0S2VLBEL DIVINE LIP GLOSS SPF 15 (OCTINOXATE AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD. (SAN JUAN, P.R)]2