Time Dynamics

Product NDC: 68828-098
11-digit product format: 688280098
Labeler code: 68828
Product ID: 68828-098_bf3b0d26-ca18-4563-821b-86c469f5c24b
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate, Zinc Oxide
Dosage form: CREAM, AUGMENTED
Route: TOPICAL
Labeler: Jafra Cosmetics International Inc
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2012-05-30
Marketing end: 0000-00-00
Substance: OCTINOXATE; ZINC OXIDE
Active strength: 4 mL/50mL; mL/50mL
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	68828-098		I	Inactivated by FDA		2026-10-12
excluded package	package	68828-098	68828-098-01	I	Inactivated by FDA		2026-10-12

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	68828-098-01	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	68828-098-01	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	68828-098-01	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	68828-098-01	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	68828-098-01	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	68828-098-01	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	68828-098-01	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	68828-098-01	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	68828-098-01	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	68828-098-01	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	68828-098-01	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	68828-098-01	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	68828-098-01	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	68828-098-01	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	68828-098-01	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	68828-098-01	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	68828-098-01	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	68828-098-01	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	68828-098-01	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	68828-098-01	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	68828-098-01	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	68828-098-01	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.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68828-098-01	2020-01-31	C162847	48780-1	9d75b9d0-d402-f424-e053-dadaa90a57ce	Time Protector Daily Defense Cream SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68828-098-01	Time DynamicsTime Protector Daily Defense SPF 15	1 in 1 CARTON	CREAM, AUGMENTED	1		1
68828-098-01	Time DynamicsTime Protector Daily Defense SPF 15	50 mL in 1 JAR	CREAM, AUGMENTED	50		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
ASCORBYL METHYLSILANOL PECTINATE	INACTIVE INGREDIENT	M3PF9237YC	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
C13-14 ISOPARAFFIN	INACTIVE INGREDIENT	E4F12ROE70	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
CERAMIDE 3	INACTIVE INGREDIENT	4370DF050B	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
CHLORELLA VULGARIS	INACTIVE INGREDIENT	RYQ4R60M02	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
CHONDRUS CRISPUS	INACTIVE INGREDIENT	OQS23HUA1X	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
DIISOPROPYL ADIPATE	INACTIVE INGREDIENT	P7E6YFV72X	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
EDETATE TRISODIUM	INACTIVE INGREDIENT	420IP921MB	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
EGG PHOSPHOLIPIDS	INACTIVE INGREDIENT	1Z74184RGV	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
LAURETH-7	INACTIVE INGREDIENT	Z95S6G8201	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
POLYACRYLAMIDE (1500 MW)	INACTIVE INGREDIENT	5D6TC4BRWV	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
SACCHARIDE ISOMERATE	INACTIVE INGREDIENT	W8K377W98I	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
SOYBEAN	INACTIVE INGREDIENT	L7HT8F1ZOD	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
TRIDECYL NEOPENTANOATE	INACTIVE INGREDIENT	3Z8H1DA7J5	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
UBIDECARENONE	INACTIVE INGREDIENT	EJ27X76M46	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1
WHEAT GERM	INACTIVE INGREDIENT	YR3G369F5A	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68828-098	TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15 (OCTINOXATE, ZINC OXIDE) CREAM, AUGMENTED [JAFRA COSMETICS INTERNATIONAL INC]	1	Legacy NDC, 2 package rows	20120615_11a9f402-2a83-4ff9-bd02-3c5a7ff34bf9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68828-098-01	68828009801	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Time Protector Daily Defense Cream SPF 15	Jafra Cosmetics International Inc \| Jafra Manufacturing, S.A. de C.V.	2012-06-13	HUMAN OTC DRUG LABEL	1