Pro-Tect Sports Sunscreen SPF 20

Product NDC: 61619-864
11-digit product format: 616190864
Labeler code: 61619
Product ID: 61619-864_d39a1b0a-6fc0-6539-e053-2995a90a06f3
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: 2016-02-05
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: 2022-12-31
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	61619-864		I	Inactivated by FDA	2026-10-05
excluded package	package	61619-864	61619-864-02	I	Inactivated by FDA	2026-10-05
excluded package	package	61619-864	61619-864-04	I	Inactivated by FDA	2026-10-05
excluded package	package	61619-864	61619-864-08	I	Inactivated by FDA	2026-10-05
excluded package	package	61619-864	61619-864-10	I	Inactivated by FDA	2026-10-05
excluded package	package	61619-864	61619-864-32	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	61619-864-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61619-864-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61619-864-32	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61619-864-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61619-864-04	`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	61619-864-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61619-864-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61619-864-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61619-864-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61619-864-04	`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	61619-864-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61619-864-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61619-864-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61619-864-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61619-864-04	`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	61619-864-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61619-864-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61619-864-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61619-864-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61619-864-04	`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	61619-864-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61619-864-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61619-864-32	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61619-864-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61619-864-04	`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	61619-864-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61619-864-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61619-864-32	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61619-864-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61619-864-04	`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	61619-864-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61619-864-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61619-864-32	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61619-864-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61619-864-04	`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	61619-864-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61619-864-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61619-864-32	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61619-864-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61619-864-04	`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	61619-864-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61619-864-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61619-864-32	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61619-864-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61619-864-04	`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	61619-864-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61619-864-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61619-864-32	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61619-864-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61619-864-04	`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
61619-864-02	62668419-e513-496f-a8d2-afbfc411e81c
61619-864-04	62668419-e513-496f-a8d2-afbfc411e81c
61619-864-08	62668419-e513-496f-a8d2-afbfc411e81c
61619-864-10	62668419-e513-496f-a8d2-afbfc411e81c
61619-864-32	62668419-e513-496f-a8d2-afbfc411e81c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61619-864-02	Pro-Tect Sports Sunscreen SPF 20	59.1 mL in 1 BOTTLE, PLASTIC	LOTION	59.1	7
61619-864-04	Pro-Tect Sports Sunscreen SPF 20	118.3 mL in 1 BOTTLE, PLASTIC	LOTION	118.3	7
61619-864-06	Pro-Tect Sports Sunscreen SPF 20	29.6 mL in 1 BOTTLE, PLASTIC	LOTION	29.6	7
61619-864-08	Pro-Tect Sports Sunscreen SPF 20	236.6 mL in 1 BOTTLE, PLASTIC	LOTION	236.6	7
61619-864-10	Pro-Tect Sports Sunscreen SPF 20	1 in 1 BOX	LOTION	1	7
61619-864-32	Pro-Tect Sports Sunscreen SPF 20	946.4 mL in 1 BOTTLE, PLASTIC	LOTION	946.4	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MERADIMATE	ACTIVE INGREDIENT	J9QGD60OUZ	PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	3
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	3
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	3
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	3
MERADIMATE	ACTIVE MOIETY	J9QGD60OUZ	PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	3
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	3
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	3
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	3
.ALPHA.-TOCOPHEROL ACETATE, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	3
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	3
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	809Y72KV36	PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	3
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	3
CETYL DIMETHICONE 45	INACTIVE INGREDIENT	IK315POC44	PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	3
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	3
DIETHANOLAMINE CETYL PHOSPHATE	INACTIVE INGREDIENT	4UG0316V9S	PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	3
IODOPROPYNYL BUTYLCARBAMATE	INACTIVE INGREDIENT	603P14DHEB	PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	3
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61619-864	PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED]	7	Legacy NDC, 6 package rows	20211222_62668419-e513-496f-a8d2-afbfc411e81c.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
61619-864-02	61619086402	59.1 mL in 1 BOTTLE, PLASTIC (61619-864-02)	59.1 ml	2016-02-05	0000-00-00	No	No	Current
61619-864-04	61619086404	118.3 mL in 1 BOTTLE, PLASTIC (61619-864-04)	118.3 ml	2016-02-05	0000-00-00	No	No	Current
61619-864-06	61619086406	29.6 mL in 1 BOTTLE, PLASTIC (61619-864-06)	29.6 ml	2016-02-05	0000-00-00	No	No	Current
61619-864-08	61619086408	236.6 mL in 1 BOTTLE, PLASTIC (61619-864-08)	236.6 ml	2016-02-05	0000-00-00	No	No	Current
61619-864-10	61619086410	1 BOTTLE, PLASTIC in 1 BOX (61619-864-10) > 29.6 mL in 1 BOTTLE, PLASTIC (61619-864-06)		2021-12-22	0000-00-00	No	No	Current
61619-864-32	61619086432	946.4 mL in 1 BOTTLE, PLASTIC (61619-864-32)	946.4 ml	2016-02-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pro-Tect Sports Sunscreen SPF 20 - A-Cute Derm, Incorporated \| Bio-Medical & Pharmaceutical Manufacturing Corporation	A-Cute Derm, Incorporated \| Bio-Medical & Pharmaceutical Manufacturing Corporation	2021-12-21	HUMAN OTC DRUG LABEL	7