Oscar de la Renta Moisturizing Sunscreen SPF 30

Product NDC: 45124-001
11-digit product format: 451240001
Labeler code: 45124
Product ID: 45124-001_7f7ff9c6-8f65-45fd-9a30-35fcee39d2fd
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE, OCTISALATE, OXYBENZONE
Dosage form: CREAM
Route: TOPICAL
Labeler: Oscar de la Renta LLC
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-04-11
Marketing end: 0000-00-00
Substance: OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength: 8 mL/100mL; mL/100mL; mL/100mL
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	45124-001		I	Inactivated by FDA		2026-08-17
excluded package	package	45124-001	45124-001-05	I	Inactivated by FDA		2026-08-17

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	45124-001-05	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	45124-001-05	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	45124-001-05	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	45124-001-05	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	45124-001-05	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	45124-001-05	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	45124-001-05	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	45124-001-05	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	45124-001-05	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	45124-001-05	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	45124-001-05	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	45124-001-05	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	45124-001-05	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	45124-001-05	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	45124-001-05	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	45124-001-05	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	45124-001-05	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	45124-001-05	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	45124-001-05	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	45124-001-05	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	45124-001-05	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	45124-001-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45124-001-05	2020-01-31	C162847	48780-1	9d75b9d0-c2fe-f424-e053-dadaa90a57ce	Oscar de la Renta Moisturizing Sunscreen Cream SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45124-001-05	Oscar de la Renta Moisturizing Sunscreen SPF 30	120 mL in 1 TUBE	CREAM	120		1
45124-001-05	Oscar de la Renta Moisturizing Sunscreen SPF 30	1 in 1 CARTON	CREAM	1		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
.ALPHA.-HEXYLCINNAMALDEHYDE	INACTIVE INGREDIENT	7X6O37OK2I	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
BENZYL SALICYLATE	INACTIVE INGREDIENT	WAO5MNK9TU	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
CETEARYL GLUCOSIDE	INACTIVE INGREDIENT	09FUA47KNA	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
COCO-GLYCERIDES	INACTIVE INGREDIENT	ISE9I7DNUG	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
CYCLOMETHICONE 6	INACTIVE INGREDIENT	XHK3U310BA	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
ETHYLHEXYL LAURATE	INACTIVE INGREDIENT	8J6M396U72	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
GERANIOL	INACTIVE INGREDIENT	L837108USY	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
HYDROXYCITRONELLOL	INACTIVE INGREDIENT	R0B4U2I48W	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
ISODECYL NEOPENTANOATE	INACTIVE INGREDIENT	W60VYE24XC	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
LINALOOL, (+/-)-	INACTIVE INGREDIENT	D81QY6I88E	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
OAT	INACTIVE INGREDIENT	Z6J799EAJK	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
POTASSIUM CETYL PHOSPHATE	INACTIVE INGREDIENT	03KCY6P7UT	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
SODIUM POLYACRYLATE (8000 MW)	INACTIVE INGREDIENT	285CYO341L	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
SOY PROTEIN	INACTIVE INGREDIENT	R44IWB3RN5	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45124-001	OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [OSCAR DE LA RENTA LLC]	1	Legacy NDC, 2 package rows	20120411_f8f16d07-e26c-46d3-818c-64f955351736.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
45124-001-05	45124000105	120 mL in 1 TUBE	120 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oscar de la Renta Moisturizing Sunscreen Cream SPF 30	Oscar de la Renta LLC \| Suite K Value Added Services LLC	2012-04-11	HUMAN OTC DRUG LABEL	1