Time Machine BB

Product NDC: 53727-103
11-digit product format: 537270103
Labeler code: 53727
Product ID: 53727-103_8a40ce01-f850-4711-94fd-5176f75f58d9
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: 2014-05-28
Marketing end: 0000-00-00
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 3 g/30g; g/30g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53727-103		I	Inactivated by FDA		2026-10-15
excluded package	package	53727-103	53727-103-01	I	Inactivated by FDA		2026-10-15

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	53727-103-01	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	53727-103-01	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	53727-103-01	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	53727-103-01	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	53727-103-01	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	53727-103-01	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	53727-103-01	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	53727-103-01	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	53727-103-01	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	53727-103-01	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	53727-103-01	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	53727-103-01	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	53727-103-01	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	53727-103-01	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	53727-103-01	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	53727-103-01	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	53727-103-01	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	53727-103-01	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	53727-103-01	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	53727-103-01	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	53727-103-01	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	53727-103-01	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#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
d676a241-be05-4740-b3ee-1a5f2ed422d2	Product name	4	20180615
dd8bd48f-20d6-43c7-b471-3ae872868afa	Product name	3	20180125
d41954ff-bc63-4b2c-aba0-9146707659d7	Product name	2	20151117
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53727-103-01	2020-01-31	C162847	48780-1	9d75b9d0-f826-f424-e053-dadaa90a57ce	49b19238-dbe7-41fd-9841-b2a0081bc495

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53727-103-01	Time Machine BB	30 g in 1 BOTTLE	CREAM	30		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
ADENOSINE	INACTIVE INGREDIENT	K72T3FS567	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
ARBUTIN	INACTIVE INGREDIENT	C5INA23HXF	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
BABASSU OIL	INACTIVE INGREDIENT	8QSB4M5477	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE	INACTIVE INGREDIENT	75D21FL1PI	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE	INACTIVE INGREDIENT	FJ1H6M2JG9	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)	INACTIVE INGREDIENT	V2W71V8T0X	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
CODONOPSIS LANCEOLATA ROOT	INACTIVE INGREDIENT	3B7455ZMXH	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
CYCLOMETHICONE 6	INACTIVE INGREDIENT	XHK3U310BA	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER	INACTIVE INGREDIENT	RSA9I561OK	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)	INACTIVE INGREDIENT	H895X08VNQ	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
DISTEARDIMONIUM HECTORITE	INACTIVE INGREDIENT	X687XDK09L	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
HEXYL LAURATE	INACTIVE INGREDIENT	4CG9F9W01Q	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
PALMITOLEIC ACID	INACTIVE INGREDIENT	209B6YPZ4I	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
PANAX GINSENG ROOT OIL	INACTIVE INGREDIENT	P9T4K47OM0	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
PHENYL TRIMETHICONE	INACTIVE INGREDIENT	DR0K5NOJ4R	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
POLYGLYCERYL-4 ISOSTEARATE	INACTIVE INGREDIENT	820DPX33S7	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
PROPYLENE CARBONATE	INACTIVE INGREDIENT	8D08K3S51E	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
ROYAL JELLY	INACTIVE INGREDIENT	L497I37F0C	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
SALVIA MILTIORRHIZA ROOT	INACTIVE INGREDIENT	1693AM5SBN	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
SCROPHULARIA BUERGERIANA ROOT	INACTIVE INGREDIENT	CYM875P4NW	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
SOPHORA FLAVESCENS ROOT	INACTIVE INGREDIENT	IYR6K8KQ5K	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
SORBITAN ISOSTEARATE	INACTIVE INGREDIENT	01S2G2C1E4	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
SORBITAN OLIVATE	INACTIVE INGREDIENT	MDL271E3GR	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53727-103	TIME MACHINE BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COSMECCA KOREA CO., LTD.]	2	Legacy NDC, 1 package rows	20140815_49b19238-dbe7-41fd-9841-b2a0081bc495.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53727-103-01	53727010301	30 g in 1 BOTTLE	30 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Time Machine BB - Cosmecca Korea Co., Ltd.	Cosmecca Korea Co., Ltd.	2014-08-15	HUMAN OTC DRUG LABEL	2