FDA.reportPublic FDA data

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
MERADIMATE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength
50; 75; 50; 30 mg/g; mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MERADIMATE50 mg/g
OCTINOXATE75 mg/g
OCTISALATE50 mg/g
OXYBENZONE30 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ9QGD60OUZ, 4Y5P7MUD51, 4X49Y0596W, 95OOS7VE0Y

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37945-862-642023-12-15C16284748780-19d75b9d0-c940-f424-e053-dadaa90a57ce16994959-cade-06de-e054-00144ff88e88
37945-862-642023-01-30C16284748780-19d75b9d0-c940-f424-e053-dadaa90a57ce16994959-cade-06de-e054-00144ff88e88
37945-862-652020-02-14C16284748780-19d75b9d0-8593-f424-e053-dadaa90a57ce66bb06fb-33d2-4b57-a65f-66bcd187c627
37945-862-662020-02-14C16284748780-19d75b9d0-8593-f424-e053-dadaa90a57ce66bb06fb-33d2-4b57-a65f-66bcd187c627
37945-862-642020-02-12C16284748780-19d75b9d0-c940-f424-e053-dadaa90a57ce16994959-cade-06de-e054-00144ff88e88
37945-862-642020-01-31C16284748780-19d75b9d0-c940-f424-e053-dadaa90a57ce16994959-cade-06de-e054-00144ff88e88
37945-862-652020-01-31C16284748780-19d75b9d0-8593-f424-e053-dadaa90a57ce66bb06fb-33d2-4b57-a65f-66bcd187c627
37945-862-662020-01-31C16284748780-19d75b9d0-8593-f424-e053-dadaa90a57ce66bb06fb-33d2-4b57-a65f-66bcd187c627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37945-862-65PRO-TECT SPORTS SUNSCREEN190 g in 1 CONTAINERLOTION19025
37945-862-64PRO-TECT SPORTS SUNSCREEN100 g in 1 BOTTLELOTION1006

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MERADIMATEACTIVE INGREDIENTJ9QGD60OUZPRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]8
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]8
OCTISALATEACTIVE INGREDIENT4X49Y0596WPRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]8
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YPRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]8
MERADIMATEACTIVE MOIETYJ9QGD60OUZPRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]8
OCTINOXATEACTIVE MOIETY4Y5P7MUD51PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]8
OCTISALATEACTIVE MOIETY4X49Y0596WPRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]8
OXYBENZONEACTIVE MOIETY95OOS7VE0YPRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]8
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]8
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XPRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]8
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHPRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]8
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT809Y72KV36PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]8
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNPRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]8
CETYL DIMETHICONE 45INACTIVE INGREDIENTIK315POC44PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]8
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]8
DIETHANOLAMINE CETYL PHOSPHATEINACTIVE INGREDIENT4UG0316V9SPRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]8
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBPRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]8
TALCINACTIVE INGREDIENT7SEV7J4R1UPRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]8
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKPRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]8
WATERINACTIVE INGREDIENT059QF0KO0RPRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]8
MERADIMATEACTIVE INGREDIENTJ9QGD60OUZPRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
OCTISALATEACTIVE INGREDIENT4X49Y0596WPRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YPRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
MERADIMATEACTIVE MOIETYJ9QGD60OUZPRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
OCTISALATEACTIVE MOIETY4X49Y0596WPRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
OXYBENZONEACTIVE MOIETY95OOS7VE0YPRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XPRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHPRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT809Y72KV36PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNPRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
CETYL DIMETHICONE 45INACTIVE INGREDIENTIK315POC44PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
DIETHANOLAMINE CETYL PHOSPHATEINACTIVE INGREDIENT4UG0316V9SPRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBPRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKPRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2
WATERINACTIVE INGREDIENT059QF0KO0RPRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37945-862PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]24Current NDC, Legacy NDC, 1 package rows20241004_66bb06fb-33d2-4b57-a65f-66bcd187c627.zip
37945-862PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]5Current NDC, Legacy NDC, 1 package rows20231216_16994959-cade-06de-e054-00144ff88e88.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37945-862-6437945086264100 g in 1 BOTTLE (37945-862-64) 100 g2015-05-270000-00-00NoNoCurrent
37945-862-6537945086265190 g in 1 CONTAINER (37945-862-65) 190 g2015-02-050000-00-00NoNoCurrent