Timeless Age Defying SPF 20

Product NDC: 57627-115
11-digit product format: 576270115
Labeler code: 57627
Product ID: 57627-115_40ef2014-88ce-4b0d-9e2c-fdfc0be386d1
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE, OXYBENZONE
Dosage form: CREAM
Route: TOPICAL
Labeler: Merle Norman
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-05-05
Marketing end: 0000-00-00
Substance: OCTINOXATE; OXYBENZONE
Active strength: 2 g/30mL; g/30mL
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	57627-115		I	Inactivated by FDA		2026-10-05
excluded package	package	57627-115	57627-115-02	I	Inactivated by FDA		2026-10-05

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 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	57627-115-02	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	57627-115-02	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	57627-115-02	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	57627-115-02	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	57627-115-02	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	57627-115-02	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	57627-115-02	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	57627-115-02	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	57627-115-02	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	57627-115-02	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	57627-115-02	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	57627-115-02	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	57627-115-02	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	57627-115-02	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	57627-115-02	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	57627-115-02	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	57627-115-02	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	57627-115-02	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	57627-115-02	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	57627-115-02	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	57627-115-02	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	57627-115-02	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
57627-115-02	2020-01-31	C162847	48780-1	9d75b9d0-18d9-f424-e053-dadaa90a57ce	Timeless Age-Defying Makeup SPF 20

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57627-115-01	Timeless Age Defying SPF 20Merle Norman	30 mL in 1 BOTTLE	CREAM	30		16
57627-115-02	Timeless Age Defying SPF 20Merle Norman	1 in 1 BOX	CREAM	1		16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
1,3-BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
CERAMIDE 3	INACTIVE INGREDIENT	4370DF050B	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
CETYL PHOSPHATE	INACTIVE INGREDIENT	VT07D6X67O	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
DIPALMITOYL HYDROXYPROLINE	INACTIVE INGREDIENT	E6AHA53N1H	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
FERROUS OXIDE	INACTIVE INGREDIENT	G7036X8B5H	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
HYALURONIC ACID	INACTIVE INGREDIENT	S270N0TRQY	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
ISODECYL NEOPENTANOATE	INACTIVE INGREDIENT	W60VYE24XC	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
MICA	INACTIVE INGREDIENT	V8A1AW0880	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
PALMITOYL OLIGOPEPTIDE	INACTIVE INGREDIENT	HO4ZT5S86C	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
PEG-12 DIMETHICONE (300 CST)	INACTIVE INGREDIENT	ZEL54N6W95	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
PHENYL TRIMETHICONE	INACTIVE INGREDIENT	DR0K5NOJ4R	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
SOYBEAN	INACTIVE INGREDIENT	L7HT8F1ZOD	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
SQUALANE	INACTIVE INGREDIENT	GW89575KF9	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
TRICAPRYLIN	INACTIVE INGREDIENT	6P92858988	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
TRILAURIN	INACTIVE INGREDIENT	7FP2Z3RVUV	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57627-115	TIMELESS AGE DEFYING SPF 20 MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN]	16	Legacy NDC, 2 package rows	20170124_cae1e33b-d41f-454d-8a16-ff41bd6663dc.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
57627-115-01	57627011501	30 mL in 1 BOTTLE	30 ml	Historical
57627-115-02	57627011502	1 in 1 BOX		Historical