Pro-Tect Sunscreen for Professionals

Product NDC: 61619-866
11-digit product format: 616190866
Labeler code: 61619
Product ID: 61619-866_b79d7feb-288f-d13f-e053-2a95a90ab7b1
Type: HUMAN OTC DRUG
Nonproprietary name: Meradimate, Octinoxate, Octisalate, Oxybenzone
Dosage form: LOTION
Route: CUTANEOUS
Labeler: A-Cute Derm, Incorporated
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2016-02-08
Marketing end: 0000-00-00
Substance: OCTINOXATE; MERADIMATE; OXYBENZONE; OCTISALATE
Active strength: 75 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61619-866		I	Inactivated by FDA	2026-10-05
excluded package	package	61619-866	61619-866-01	I	Inactivated by FDA	2026-10-05
excluded package	package	61619-866	61619-866-02	I	Inactivated by FDA	2026-10-05
excluded package	package	61619-866	61619-866-04	I	Inactivated by FDA	2026-10-05
excluded package	package	61619-866	61619-866-08	I	Inactivated by FDA	2026-10-05
excluded package	package	61619-866	61619-866-32	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 2 · 90 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61619-866-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61619-866-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61619-866-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61619-866-32	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61619-866-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61619-866-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61619-866-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61619-866-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61619-866-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61619-866-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61619-866-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61619-866-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61619-866-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61619-866-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61619-866-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61619-866-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61619-866-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61619-866-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61619-866-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61619-866-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61619-866-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61619-866-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61619-866-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61619-866-32	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61619-866-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61619-866-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61619-866-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61619-866-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61619-866-32	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61619-866-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61619-866-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61619-866-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61619-866-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61619-866-32	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61619-866-04	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61619-866-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61619-866-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61619-866-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61619-866-32	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61619-866-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61619-866-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61619-866-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61619-866-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61619-866-32	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61619-866-04	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61619-866-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61619-866-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61619-866-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61619-866-32	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61619-866-04	`ad56d346431e…`	`cc804d4bbf1e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
61619-866-01	9604b7d9-d7fc-4cce-ad11-befb7c281fff
61619-866-02	9604b7d9-d7fc-4cce-ad11-befb7c281fff
61619-866-04	9604b7d9-d7fc-4cce-ad11-befb7c281fff
61619-866-08	9604b7d9-d7fc-4cce-ad11-befb7c281fff
61619-866-32	9604b7d9-d7fc-4cce-ad11-befb7c281fff

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61619-866-01	Pro-Tect Sunscreen for Professionals	29.6 mL in 1 BOTTLE, PLASTIC	LOTION	29.6	5
61619-866-02	Pro-Tect Sunscreen for Professionals	59.1 mL in 1 BOTTLE, PLASTIC	LOTION	59.1	5
61619-866-04	Pro-Tect Sunscreen for Professionals	118.3 mL in 1 BOTTLE, PLASTIC	LOTION	118.3	5
61619-866-08	Pro-Tect Sunscreen for Professionals	236.6 mL in 1 BOTTLE, PLASTIC	LOTION	236.6	5
61619-866-32	Pro-Tect Sunscreen for Professionals	946.4 mL in 1 BOTTLE, PLASTIC	LOTION	946.4	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MERADIMATE	ACTIVE INGREDIENT	J9QGD60OUZ	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
MERADIMATE	ACTIVE MOIETY	J9QGD60OUZ	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
.ALPHA.-TOCOPHEROL ACETATE, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	809Y72KV36	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
CETYL DIMETHICONE 45	INACTIVE INGREDIENT	IK315POC44	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
DIETHANOLAMINE CETYL PHOSPHATE	INACTIVE INGREDIENT	4UG0316V9S	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
EICOSYL POVIDONE	INACTIVE INGREDIENT	XQQ9MKE2BJ	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
IODOPROPYNYL BUTYLCARBAMATE	INACTIVE INGREDIENT	603P14DHEB	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	PRO-TECT SPF 30 PLUS BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61619-866	PRO-TECT SUNSCREEN FOR PROFESSIONALS (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	5	Legacy NDC, 5 package rows	20201230_9604b7d9-d7fc-4cce-ad11-befb7c281fff.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
J9QGD60OUZ	MERADIMATE	134-09-8	MERADIMATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61619-866-01	61619086601	29.6 mL in 1 BOTTLE, PLASTIC (61619-866-01)	29.6 ml	2016-02-08	0000-00-00	No	No	Current
61619-866-02	61619086602	59.1 mL in 1 BOTTLE, PLASTIC (61619-866-02)	59.1 ml	2016-02-08	0000-00-00	No	No	Current
61619-866-04	61619086604	118.3 mL in 1 BOTTLE, PLASTIC (61619-866-04)	118.3 ml	2016-02-08	0000-00-00	No	No	Current
61619-866-08	61619086608	236.6 mL in 1 BOTTLE, PLASTIC (61619-866-08)	236.6 ml	2016-02-08	0000-00-00	No	No	Current
61619-866-32	61619086632	946.4 mL in 1 BOTTLE, PLASTIC (61619-866-32)	946.4 ml	2016-02-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pro-Tect Sunscreen for Professionals - A-Cute Derm, Incorporated \| Bio-Medical & Pharmaceutical Manufacturing Corporation	A-Cute Derm, Incorporated \| Bio-Medical & Pharmaceutical Manufacturing Corporation	2020-12-29	HUMAN OTC DRUG LABEL	5