Home NDC 53727-101 Always Triple BB
Product NDC 53727-101
11-digit product format 537270101
Labeler code 53727
Product ID 53727-101_a2ce1edd-0109-45ca-a77d-3181fbb69a23
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Cosmecca Korea Co., Ltd.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-05-27
Marketing end 0000-00-00
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 5 g/50g; g/50g
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record 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 date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53727-101-01 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53727-101-01 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53727-101-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53727-101-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53727-101-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53727-101-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53727-101-01 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53727-101-01 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53727-101-01 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53727-101-01 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53727-101-01 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53727-101-01 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53727-101-01 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53727-101-01 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53727-101-01 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53727-101-01 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53727-101-01 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53727-101-01 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53727-101-01 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53727-101-01 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53727-101-01 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53727-101-01 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53727-101-01 Always Triple BB 50 g in 1 BOTTLE CREAM 50 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TITANIUM DIOXIDE ACTIVE INGREDIENT 15FIX9V2JP ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 TITANIUM DIOXIDE ACTIVE MOIETY 15FIX9V2JP ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 ZINC CATION ACTIVE MOIETY 13S1S8SF37 ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 ADENOSINE INACTIVE INGREDIENT K72T3FS567 ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 ARBUTIN INACTIVE INGREDIENT C5INA23HXF ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE INACTIVE INGREDIENT 55A74AJ3KB ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 BUTYLENE GLYCOL INACTIVE INGREDIENT 3XUS85K0RA ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE INACTIVE INGREDIENT 75D21FL1PI ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 CAVIAR, UNSPECIFIED INACTIVE INGREDIENT 020K6HLU0O ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 CERESIN INACTIVE INGREDIENT Q1LS2UJO3A ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 CHLORPHENESIN INACTIVE INGREDIENT I670DAL4SZ ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 CYCLOMETHICONE INACTIVE INGREDIENT NMQ347994Z ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 CYCLOMETHICONE 5 INACTIVE INGREDIENT 0THT5PCI0R ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER INACTIVE INGREDIENT RSA9I561OK ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) INACTIVE INGREDIENT H895X08VNQ ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 DISTEARDIMONIUM HECTORITE INACTIVE INGREDIENT X687XDK09L ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 HEXYL LAURATE INACTIVE INGREDIENT 4CG9F9W01Q ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 HYALURONATE SODIUM INACTIVE INGREDIENT YSE9PPT4TH ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 MALPIGHIA GLABRA FRUIT INACTIVE INGREDIENT B94O42LA9M ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 PHENYL TRIMETHICONE INACTIVE INGREDIENT DR0K5NOJ4R ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 PROPYLENE CARBONATE INACTIVE INGREDIENT 8D08K3S51E ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE INACTIVE INGREDIENT O4446S9CRA ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 ROSA CANINA FRUIT OIL INACTIVE INGREDIENT CR7307M3QZ ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 ROYAL JELLY INACTIVE INGREDIENT L497I37F0C ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 SORBITAN SESQUIOLEATE INACTIVE INGREDIENT 0W8RRI5W5A ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 TRIETHOXYCAPRYLYLSILANE INACTIVE INGREDIENT LDC331P08E ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53727-101 ALWAYS TRIPLE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.] 4 Legacy NDC, 1 package rows 20140819_b05d7db4-442a-4da6-aea6-423d637c71db.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 53727-101-01 53727010101 50 g in 1 BOTTLE 50 g Historical