PRO-TECT SPORTS SUNSCREEN

Manufacturer: Bio-Medical & Pharmaceutical Manufacturing Corporation
Effective date: 2025-12-03
Label type: HUMAN OTC DRUG LABEL
Version: 25
Source: full-release
Hydrated at: 2026-06-01 01:19:23

Label at a glance#

ProductPRO-TECT SPORTS SUNSCREEN

Active ingredientOCTINOXATE, MERADIMATE, OXYBENZONE, OCTISALATE

Label structure10 sections

Indications and uses

•helps prevent sunburn. •if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

•apply liberally 15 minutes before sun exposure •reapply: •after 80 minutes of swimming or sweating •immediately after towel drying •at least every 2 hours •children under 6 months: Ask a doctor •Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun pro...

Contacts and useful links#

PhoneLabel contact281-835-8051

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Meradimate 5.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 3.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

•helps prevent sunburn.
•if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.
Do not use on damaged or broken skin.
Stop use and ask a doctor if rash occurs.
When using this product keep out of eyes. Rinse with water to remove.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

•apply liberally 15 minutes before sun exposure
•reapply: •after 80 minutes of swimming or sweating •immediately after towel drying •at least every 2 hours
•children under 6 months: Ask a doctor
•Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: •limit time in the sun, especially from 10 a.m.–2 p.m. •wear long-sleeved shirts, pants, hats, and sun-glasses

Other Information

OTHER SAFETY INFORMATION

•protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Leaf, Benzyl Alcohol, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked), Cetyl Alcohol, Cetyl Dimethicone 45, Diazolidinyl Urea, Diethanolamine Cetyl Phosphate, dl-Alpha Tocopheryl Acetate, Iodopropynyl Butylcarbamate, Stearic Acid, Talc, Trolamine, Water.

Questions or Comments

OTC - QUESTIONS SECTION

281-835-8051

Bio-Medical & Pharm. Mfg. Corp.

RECENT MAJOR CHANGES SECTION

uses 07/2021

directions 07/2021

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pro-tect spf 20 6.4 oz

spf 20

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
37945-862-65	2020-02-14	C162847	48780-1	9d75b9d0-8593-f424-e053-dadaa90a57ce	66bb06fb-33d2-4b57-a65f-66bcd187c627
37945-862-66	2020-02-14	C162847	48780-1	9d75b9d0-8593-f424-e053-dadaa90a57ce	66bb06fb-33d2-4b57-a65f-66bcd187c627
37945-862-65	2020-01-31	C162847	48780-1	9d75b9d0-8593-f424-e053-dadaa90a57ce	66bb06fb-33d2-4b57-a65f-66bcd187c627
37945-862-66	2020-01-31	C162847	48780-1	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

DailyMed Socrata Ingredients#

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

PRO-TECT SPORTS SUNSCREEN
Meradimate, Octinoxate, Octisalate, Oxybenzone
OCTINOXATE
MERADIMATE
OXYBENZONE
WATER
ALOE VERA LEAF
IODOPROPYNYL BUTYLCARBAMATE
STEARIC ACID
TALC
TROLAMINE
BENZYL ALCOHOL
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
CETYL ALCOHOL
CETYL DIMETHICONE 45
DIAZOLIDINYL UREA
DIETHANOLAMINE CETYL PHOSPHATE
.ALPHA.-TOCOPHEROL ACETATE, DL-
OCTISALATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37945-862	37945-862-65

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
MERADIMATE	J9QGD60OUZ	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
WATER	059QF0KO0R	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
IODOPROPYNYL BUTYLCARBAMATE	603P14DHEB	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TALC	7SEV7J4R1U	IACT
TROLAMINE	9O3K93S3TK	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	IACT
CETYL ALCOHOL	936JST6JCN	IACT
CETYL DIMETHICONE 45	IK315POC44	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
DIETHANOLAMINE CETYL PHOSPHATE	4UG0316V9S	IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	IACT
OCTISALATE	4X49Y0596W	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 86 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		18 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED / ORAL		87 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	ELIXIR / ORAL	4.5 mg/5ml		Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, CHEWABLE / ORAL		202 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	LOTION / TOPICAL		4000 mg	Exact identifier — unii+dosage form 2 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	DROPS / ORAL	NA		Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE / ORAL		729 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii+dosage form 2 equally ranked IID candidates
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+dosage form 2 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	POWDER, FOR SUSPENSION / ORAL		735 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, EXTENDED RELEASE / ORAL		300 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED, EXTENDED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / BUCCAL	15 mg		Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE / ORAL		322 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED, EXTENDED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE PARTICLES / ORAL		56 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	SUSPENSION, EXTENDED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE, DELAYED RELEASE / ORAL		525 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE, FOR SUSPENSION / ORAL		296 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / RECTAL	32.4 mg		Exact identifier — unii candidate 70 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-	.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	AEROSOL, FOAM / TOPICAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FOR SUSPENSION / ORAL		24 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	SUSPENSION, EXTENDED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-	.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	SUSPENSION / ORAL		234 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	PELLET / ORAL		69 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / BUCCAL	15 mg		Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE, FOR SUSPENSION / ORAL		296 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-	.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	AEROSOL, FOAM / TOPICAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING / ORAL		80 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING / ORAL		80 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii+dosage form 2 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		357 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE / ORAL		349 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	DROPS / ORAL	NA		Exact identifier — unii candidate 70 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii+dosage form 2 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / ORAL	1000 mg		Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GUM, CHEWING / BUCCAL	NA		Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE / ORAL		729 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE, DELAYED RELEASE / ORAL		525 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+dosage form 2 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED / ORAL		87 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, EXTENDED RELEASE / ORAL		300 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GUM, CHEWING / BUCCAL	NA		Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE / ORAL		322 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	POWDER, FOR SUSPENSION / ORAL		735 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE / ORAL		349 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / RECTAL	32.4 mg		Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		357 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 70 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		18 mg	Exact identifier — unii candidate 70 equally ranked IID candidates

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRO-TECT SPORTS SUNSCREEN	MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bio-Medical & Pharmaceutical Manufacturing Corporation	16994959-cade-06de-e054-00144ff88e88	2025-12-03	Warnings	Exact identifier ndc (product): 37945-862
PRO-TECT SPORTS SUNSCREEN	MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bio-Medical & Pharmaceutical Manufacturing Corporation	66bb06fb-33d2-4b57-a65f-66bcd187c627	2025-12-03	Warnings	Exact identifier ndc (package): 37945-862-65 ndc (product): 37945-862 ndc11 (package): 37945086265 spl id: 450fca6c-31a1-cde7-e063-6394a90a30c8 spl set id: 66bb06fb-33d2-4b57-a65f-66bcd187c627

Reported adverse events (FAERS/openFDA)#

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