PRO-TECT SPORTS SUNSCREEN

Product NDC
37945-862
Requested package NDC
37945-862-64
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

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage37945-86237945-862-64EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
J9QGD60OUZInternal UNII lookup
95OOS7VE0YInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
16994959-cade-06de-e054-00144ff88e88Available on FDA.report

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#

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

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 1 of 363 · 7,243 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm DuskSPF50Grace And Fire USA Inc.2735ab0f-5eec-04c5-e063-6394a90aa60e2026-10-01WarningsExact identifier
application number: M020
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm BejewelledSPF50Grace And Fire USA Inc.274a0544-6c71-4d91-e063-6394a90a22472026-10-01WarningsExact identifier
application number: M020
TRILIPIDERM All-Body Moisture Retention SPF-30AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENETrilipid Research Institute, LLC7f34de0a-eeb3-4b71-9abd-53d03266d9932026-09-10WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC6a43173f-41f9-4207-a0db-53bc8db6f4a42026-09-10WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCd69b4992-d7e6-4bd7-b144-0485e35818a62026-09-10WarningsExact identifier
application number: M020
Hydra Finish SPF 15HOMOSALATE, OCTINOXATEGuinot4047e8ec-834a-41e6-a144-5649a7718de42026-09-10WarningsExact identifier
application number: M020
HYDRA BEAUTE SPF 15AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEGuinot806d1e18-a3fc-43df-a52a-a640902d08872026-09-10WarningsExact identifier
application number: M020
Pur Confort SPF 15AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEGuinot2fe0656f-f924-48da-91bf-d6f3d98e8fd92026-09-10WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC51f3d6ca-3189-4380-9afb-4259ba8782742026-09-10WarningsExact identifier
application number: M020
Sun Logic Creme Solaire Visage et corps SPF 30AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEGuinotb0a95379-998a-4cda-bae7-63faf3d6f3c82026-09-10WarningsExact identifier
application number: M020
Sun Logic Lait Solaire Corps SPF 20AVOBENZONE, HOMOSALATE, OCTOCRYLENEGuinotd9d2cee0-9189-42d0-b1ab-78b97141b1282026-09-10WarningsExact identifier
application number: M020
SunscreenBROAD SPECTRUM SPF 301226 W AESTHETICS5b0ef395-a7dd-378e-e063-6394a90a5dce2026-09-09WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
application number: M020
Baloom 2% Panthenol Hydro Airy SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE. OCTOCRYLENEARSN KOREA5148b638-f8a4-fa8b-e063-6294a90ac2082026-09-08WarningsExact identifier
application number: M020
Haruharu Wonder - Centella Calm Cloud SPFAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDFS Company4eee0e75-201c-6d98-e063-6394a90ab7c42026-09-08WarningsExact identifier
application number: M020
Double-Duty Face MoisturizerMOSITURIZING SUNSCREENJack Black, LLC672be406-e3a1-47b4-8ef6-ee2b62baae962026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Pineapple MintSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC0862534c-5f48-4f67-a3b8-0876a667556f2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin ELIP BALM SPF25Jack Black, LLC88e8752d-1fbf-4e28-b79d-7c05ecdce8422026-09-08WarningsExact identifier
application number: M020
Jack Black Intense Lip Therapy SPF25, Natural Mint and Shea ButterLIP BALM SUNSCREENJack Black, LLCe8730127-2d8d-4b80-ab90-d2f136d9e5162026-09-08WarningsExact identifier
application number: M020
Jack Black Intense Therapy Lip Balm SPF25, Grapefruit and GingerLIP BALM SUNSCREENJack Black, LLCd961d22a-2125-41e9-94a3-5b53d12b320f2026-09-08WarningsExact identifier
application number: M020

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