PRO-TECT SPORTS SUNSCREEN

Product NDC: 37945-862
11-digit product format: 379450862
Labeler code: 37945
Product ID: 37945-862_450fc7aa-e2e3-c6ff-e063-6394a90a1035
Type: HUMAN OTC DRUG
Nonproprietary name: Meradimate, Octinoxate, Octisalate, Oxybenzone
Dosage form: LOTION
Route: CUTANEOUS
Labeler: Bio-Medical & Pharmaceutical Manufacturing Corporation
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-05-27
Substance: OCTINOXATE; MERADIMATE; OXYBENZONE; OCTISALATE
Active strength: 75; 50; 30; 50 mg/g; mg/g; mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
unfinished product	product	37945-862		UNFINISHED	Active or certified unfinished drug listing	2026-11-13
unfinished package	package	37945-862	37945-862-10	UNFINISHED	Active or certified unfinished drug listing	2026-11-13
unfinished package	package	37945-862	37945-862-20	UNFINISHED	Active or certified unfinished drug listing	2026-11-13

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 · 46 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	Archive	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	37945-862-10	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	37945-862-20	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	37945-862-10	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	37945-862-20	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	37945-862-10	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	37945-862-20	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	37945-862-10	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	37945-862-20	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	37945-862-10	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	37945-862-20	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	37945-862-10	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	37945-862-20	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	37945-862-10	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	37945-862-20	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	37945-862-10	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	37945-862-20	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	37945-862-10	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	37945-862-20	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	37945-862-10	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	37945-862-20	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	37945-862-10	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	37945-862-20	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	37945-862-10	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	37945-862-20	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	37945-862-10	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	37945-862-20	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	37945-862-10	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	37945-862-20	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	37945-862-64	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	37945-862-65	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: PRO-TECT SPORTS SUNSCREEN
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	75 mg/g
MERADIMATE	50 mg/g
OXYBENZONE	30 mg/g
OCTISALATE	50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Y5P7MUD51	Internal UNII lookup
J9QGD60OUZ	Internal UNII lookup
95OOS7VE0Y	Internal UNII lookup
4X49Y0596W	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
16994959-cade-06de-e054-00144ff88e88	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
37945-862-64	2023-12-15	9d75b9d0-c940-f424-e053-dadaa90a57ce	16994959-cade-06de-e054-00144ff88e88
37945-862-64	2023-01-30	9d75b9d0-c940-f424-e053-dadaa90a57ce	16994959-cade-06de-e054-00144ff88e88
37945-862-65	2020-02-14	9d75b9d0-8593-f424-e053-dadaa90a57ce	66bb06fb-33d2-4b57-a65f-66bcd187c627
37945-862-66	2020-02-14	9d75b9d0-8593-f424-e053-dadaa90a57ce	66bb06fb-33d2-4b57-a65f-66bcd187c627
37945-862-64	2020-02-12	9d75b9d0-c940-f424-e053-dadaa90a57ce	16994959-cade-06de-e054-00144ff88e88
37945-862-64	2020-01-31	9d75b9d0-c940-f424-e053-dadaa90a57ce	16994959-cade-06de-e054-00144ff88e88
37945-862-65	2020-01-31	9d75b9d0-8593-f424-e053-dadaa90a57ce	66bb06fb-33d2-4b57-a65f-66bcd187c627
37945-862-66	2020-01-31	9d75b9d0-8593-f424-e053-dadaa90a57ce	66bb06fb-33d2-4b57-a65f-66bcd187c627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
37945-862-65	PRO-TECT SPORTS SUNSCREEN	190 g in 1 CONTAINER	LOTION	190		25
37945-862-64	PRO-TECT SPORTS SUNSCREEN	100 g in 1 BOTTLE	LOTION	100		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MERADIMATE	ACTIVE INGREDIENT	J9QGD60OUZ	PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	8
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	8
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	8
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	8
MERADIMATE	ACTIVE MOIETY	J9QGD60OUZ	PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	8
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	8
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	8
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	8
.ALPHA.-TOCOPHEROL ACETATE, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	8
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	8
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	8
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	809Y72KV36	PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	8
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	8
CETYL DIMETHICONE 45	INACTIVE INGREDIENT	IK315POC44	PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	8
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	8
DIETHANOLAMINE CETYL PHOSPHATE	INACTIVE INGREDIENT	4UG0316V9S	PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	8
IODOPROPYNYL BUTYLCARBAMATE	INACTIVE INGREDIENT	603P14DHEB	PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	8
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	8
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	8
MERADIMATE	ACTIVE INGREDIENT	J9QGD60OUZ	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	2
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	2
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	2
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	2
MERADIMATE	ACTIVE MOIETY	J9QGD60OUZ	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	2
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	2
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	2
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	2
.ALPHA.-TOCOPHEROL ACETATE, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	2
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	809Y72KV36	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	2
CETYL DIMETHICONE 45	INACTIVE INGREDIENT	IK315POC44	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	2
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	2
DIETHANOLAMINE CETYL PHOSPHATE	INACTIVE INGREDIENT	4UG0316V9S	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	2
IODOPROPYNYL BUTYLCARBAMATE	INACTIVE INGREDIENT	603P14DHEB	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37945-862	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	24	Current NDC, Legacy NDC, 1 package rows	20241004_66bb06fb-33d2-4b57-a65f-66bcd187c627.zip
37945-862	PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]	5	Current NDC, Legacy NDC, 1 package rows	20231216_16994959-cade-06de-e054-00144ff88e88.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 279 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kroger Dry Oil Tanning Sunscreen Broad Spectrum SPF 15 Reef Friendly	AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE	THE KROGER COMPANY	c706aaf0-a978-7848-e053-2995a90a0aca	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Ultimate Sheer Sun Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	TOPCO ASSOCIATES LLC	c51029f4-ede0-08ef-e053-2995a90aecaf	2024-10-15	Warnings	Exact identifier application number: M020
TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 30	AVOBENZONE, HOMOSALATE, OCTOCRYLENE,	TOPCO ASSOCIATES LLC	c8af028e-9d68-4023-e053-2995a90ad18a	2024-10-15	Warnings	Exact identifier application number: M020
TOPCARE EVERYDAY ULTRA PROTECTION SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	c5601d22-2353-7319-e053-2a95a90a16c0	2024-10-15	Warnings	Exact identifier application number: M020
TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	c8c12a5a-59f5-6515-e053-2995a90a58f7	2024-10-15	Warnings	Exact identifier application number: M020
Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	c6268778-8dcc-24b6-e053-2995a90acf03	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Sport Sun SPF 50	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	f0de2999-f12b-89b1-e053-2a95a90ac610	2024-10-15	Warnings	Exact identifier application number: M020
TOPCO TOPCARE EVERYDAY MINERAL SUNSCREEN ZINC OXIDE SPF 50	ZINC OXIDE	TOPCO ASSOCIATES LLC	d501a94e-3bcd-d8e4-e053-2a95a90a33b0	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Kids Mineral Sunscreen	ZINC OXIDE	TOPCO ASSOCIATES LLC	dbee42c8-9cae-7a81-e053-2a95a90a2329	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Sport Sun Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	f12c09b1-8ffe-4933-e053-2995a90a434f	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Mineral Sunscreen Zinc Oxide SPF 30	ZINC OXIDE	TOPCO ASSOCIATES LLC	dbf03882-ab1a-9805-e053-2995a90a7109	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Mineral Sunscreen Continuous Broad Spectrum SPF 50 Reef-Conscious Formula	TITANIUM DIOXIDE, ZINC OXIDE	TOPCO ASSOCIATES LLC	f14f43e6-ee57-5495-e053-2a95a90a4011	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Sport Continuous Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	TOPCO ASSOCIATES LLC	f31ea60e-1f52-c55f-e053-2a95a90afe64	2024-10-15	Warnings	Exact identifier application number: M020
Topco Topcare Everyday Mineral Sunscreen Continuous SPF 30	ZINC OXIDE	TOPCO ASSOCIATES LLC	f71e019b-392a-f8eb-e053-6394a90a871e	2024-10-15	Warnings	Exact identifier application number: M020
TOPCARE EVERYDAY SPORT SPF 70 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	TOPCO ASSOCIATES LLC	a5b06600-f2b0-6d9b-e053-2995a90a59f0	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Ultra Protection Sun SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	f41d4c46-7998-afe6-e053-2995a90ab361	2024-10-15	Warnings	Exact identifier application number: M020
TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50	OCTISALATE, ZINC OXIDE	TOPCO ASSOCIATES LLC	f71c9060-3daf-e1be-e053-6294a90a4f91	2024-10-15	Warnings	Exact identifier application number: M020
MINERAL SUNSCREEN SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	TOPCO ASSOCIATES LLC	bfe076fa-f21f-2c46-e053-2a95a90acee4	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Mineral Sunscreen Stick	ZINC OXIDE	H.E.B.	f58f0199-bf22-2197-e053-2995a90ae64f	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Kids Blue Mineral Sunscreen Stick Berry Scented	ZINC OXIDE	H.E.B.	f58d328c-8b30-b4d4-e053-2a95a90adb59	2024-10-15	Warnings	Exact identifier application number: M020

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
37945-862-10	37945086210	185973 g in 1 DRUM (37945-862-10)	185973 g	26-MAY-22				Current
37945-862-20	37945086220	18144 g in 1 PAIL (37945-862-20)	18144 g	12-MAY-23				Current
37945-862-64	37945086264	100 g in 1 BOTTLE (37945-862-64)	100 g	2015-05-27	0000-00-00	No	No	Current
37945-862-65	37945086265	190 g in 1 CONTAINER (37945-862-65)	190 g	2015-02-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pro-Tect Sports Sunscreen SPF 20 - ABBE Laboratories, Inc.	ABBE Laboratories, Inc.	2026-04-09	HUMAN OTC DRUG LABEL	5
OCTINOXATE - Bio-Medical & Pharmaceutical Manufacturing Corporation	Bio-Medical & Pharmaceutical Manufacturing Corporation	2025-12-03	HUMAN OTC DRUG LABEL	25
OCTINOXATE - Bio-Medical & Pharmaceutical Manufacturing Corporation	Bio-Medical & Pharmaceutical Manufacturing Corporation	2025-12-03	HUMAN OTC DRUG LABEL	6