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 221 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sun Shades Lip Balm Cranberry Tangerine	AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%	Melaleuca Inc.	f39606be-19c8-58d1-e053-2a95a90a908f	2025-03-20	Warnings	Exact identifier application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 15)	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	aa937596-2378-469f-a0e1-9700044e83b3	2025-03-20	Warnings	Exact identifier application number: M020
Obagi Medical Way to Glow Kit	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	f6f6e219-4ef6-be3b-e053-6294a90a660d	2025-03-20	Warnings	Exact identifier application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 20)	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	e8d19915-8996-42df-a47b-2ce00d2bbe68	2025-03-20	Warnings	Exact identifier application number: M020
SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42	ENSULIZOLE, HOMOSALATE, OCTISALATE, AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	21bde283-a554-45c8-8733-2a8adeff41b1	2025-03-20	Warnings	Exact identifier application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR	OCTISALATE, HOMOSALATE, OCTOCRYLENE, AND AVOBENZONE	SHISEIDO AMERICAS CORPORATION	7a98171f-bf21-40d4-bc78-883aa0b0c438	2025-03-20	Warnings	Exact identifier application number: M020
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	5e2d7c94-d70a-47e4-9a4b-5953fe38ede2	2025-03-19	Warnings	Exact identifier application number: M020
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	50206f9e-2dd5-494f-9eed-f7d7ea6efda9	2025-03-18	Warnings	Exact identifier application number: M020
Hello Sun Silky Glow Broad Spectrum SPF40	ZINC OXIDE	The Creme Shop	30a4280b-4a9f-4c18-e063-6394a90a85e6	2025-03-18	Warnings	Exact identifier application number: M020
Vertra Invisible Sunscreen Face Stick Broad Spectrum SPF 45	ZINC OXIDE	Eai-jr 286, Inc	30a5ec14-63d7-e678-e063-6294a90abb57	2025-03-18	Warnings	Exact identifier application number: M020
EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Extra Shade, LLC	d197dfe3-c754-4a3d-9edd-335f3fce105c	2025-03-18	Warnings	Exact identifier application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	c88e44da-0b0e-4744-8b4b-4d9d418f29d7	2025-03-18	Warnings	Exact identifier application number: M020
MDP UV BIO SUNSCREEN	ZINC OXIDE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	SKINIDEA CO., LTD	3087771e-2ab8-2198-e063-6294a90a37d4	2025-03-17	Warnings	Exact identifier application number: M020
belif Dew guard - milky sun serum Broad Spectrum SPF 40 sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H CO., LTD.	2b38da59-b83e-4285-e063-6294a90ac6a7	2025-03-17	Warnings	Exact identifier application number: M020
SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	263ef8e8-e0c4-42e6-bb26-7581a437b35a	2025-03-14	Warnings	Exact identifier application number: M020
Impact Melanoma SPF 30	ZINC OXIDE	RENU LABORATORIES, LLC	f953302e-f712-129a-e053-6294a90ab9a8	2025-03-13	Warnings	Exact identifier application number: M020
Vertra Ehukai Beige Sunscreen Face Stick Broad Spectrum SPF 38	TITANIUM DIOXIDE	Eai-jr 286, Inc	303d5d5a-4c7a-1e23-e063-6294a90a0e58	2025-03-13	Warnings	Exact identifier application number: M020
belif Dew guard - daily mineral sunscreen Broad Spectrum SPF 50	ZINC OXIDE	LG H&H CO., LTD.	2b4c363b-f767-7901-e063-6394a90adba5	2025-03-13	Warnings	Exact identifier application number: M020
Zinc Oxide	MINERAL SUNSHIELD UNIVERSAL TINT BROAD SPECTRUM SPF 30 SUNSCREEN	Vege Labs LLC	303e84e1-3bea-ea6f-e063-6294a90aeaa7	2025-03-13	Warnings	Exact identifier application number: M020
MURASAKI BEAUTY Silicence Scar Gel SPF 30	ZINC OXIDE, ETHYLHEXYL METHOXYCINNAMATE	Haikou Pucao Trading Co.,Ltd	303f7dd6-aef2-30ce-e063-6394a90ac00f	2025-03-13	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