PRO-TECT SUNSCREEN FOR PROFESSIONALS

Manufacturer: Bio-Medical & Pharmaceutical Manufacturing Corporation
Effective date: 2025-12-03
Label type: HUMAN OTC DRUG LABEL
Version: 15
Source: full-release
Hydrated at: 2026-06-01 01:19:17

Label at a glance#

ProductPRO-TECT SUNSCREEN FOR PROFESSIONALS

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 su...

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 5.0%

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

Other Information

OTHER SAFETY INFORMATION

• protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Leaf, Benzyl Alcohol, C18-36 Acid Glycol Ester, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked), Cetyl Alcohol, Cetyl Dimethicone 45, Diazolidinyl Urea, Diethanolamine Cetyl Phosphate, dl-Alpha Tocopheryl Acetate, Eicosyl Povidone, Iodopropynyl Butylcarbamate, Lanolin, Mineral Oil, Stearic Acid, Talc, Trolamine, Water.

Questions or Comments

OTC - QUESTIONS SECTION

281-835-8051 | Bio-Med & Pharm. Mfg. Corp.

RECENT MAJOR CHANGES SECTION

uses 06/2021

directions 06/2021

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUNSCREEN FOR PROFESSIONALS

PRO-SPECTRUM PROCESS BROAD-SPECTRUM UVA/UVB SUNSCREEN

PRO-TECT

Water-Resistant

Fragrance-Free

Aloe & vitamin E

spf 30

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
37945-860-64	2025-12-03	C162847	48780-1	9d75b9d0-b18b-f424-e053-dadaa90a57ce	374e172b-90e8-4fca-8934-dee3ed7b599d
37945-860-65	2025-12-03	C162847	48780-1	9d75b9d0-b18b-f424-e053-dadaa90a57ce	374e172b-90e8-4fca-8934-dee3ed7b599d
37945-860-64	2025-01-30	C162847	48780-1	9d75b9d0-b18b-f424-e053-dadaa90a57ce	374e172b-90e8-4fca-8934-dee3ed7b599d
37945-860-65	2025-01-30	C162847	48780-1	9d75b9d0-b18b-f424-e053-dadaa90a57ce	374e172b-90e8-4fca-8934-dee3ed7b599d
37945-860-65	2020-02-14	C162847	48780-1	9d75b9d0-b18b-f424-e053-dadaa90a57ce	374e172b-90e8-4fca-8934-dee3ed7b599d
37945-860-66	2020-02-14	C162847	48780-1	9d75b9d0-b18b-f424-e053-dadaa90a57ce	374e172b-90e8-4fca-8934-dee3ed7b599d
37945-860-65	2020-01-31	C162847	48780-1	9d75b9d0-b18b-f424-e053-dadaa90a57ce	374e172b-90e8-4fca-8934-dee3ed7b599d
37945-860-66	2020-01-31	C162847	48780-1	9d75b9d0-b18b-f424-e053-dadaa90a57ce	374e172b-90e8-4fca-8934-dee3ed7b599d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
37945-860-64	PRO-TECT SUNSCREEN FOR PROFESSIONALS	100 g in 1 CONTAINER	LOTION	100		15
37945-860-65	PRO-TECT SUNSCREEN FOR PROFESSIONALS	190 g in 1 CONTAINER	LOTION	190		15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MERADIMATE	ACTIVE INGREDIENT	J9QGD60OUZ	10
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	10
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	10
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	10
MERADIMATE	ACTIVE MOIETY	J9QGD60OUZ	10
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	10
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	10
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	10
.ALPHA.-TOCOPHEROL ACETATE, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	10
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	10
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	10
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	809Y72KV36	10
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	10
CETYL DIMETHICONE 45	INACTIVE INGREDIENT	IK315POC44	10
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	10
DIETHANOLAMINE CETYL PHOSPHATE	INACTIVE INGREDIENT	4UG0316V9S	10
EICOSYL POVIDONE	INACTIVE INGREDIENT	XQQ9MKE2BJ	10
IODOPROPYNYL BUTYLCARBAMATE	INACTIVE INGREDIENT	603P14DHEB	10
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	10
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	10
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	10
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	10
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	10
WATER	INACTIVE INGREDIENT	059QF0KO0R	10

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

PRO-TECT SUNSCREEN FOR PROFESSIONALS
Meradimate, Octinoxate, Octisalate, Oxybenzone
OCTINOXATE
MERADIMATE
OXYBENZONE
WATER
ALOE VERA LEAF
LANOLIN
IODOPROPYNYL BUTYLCARBAMATE
STEARIC ACID
MINERAL OIL
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-
EICOSYL POVIDONE
OCTISALATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37945-860	37945-860-64, 37945-860-65

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
LANOLIN	7EV65EAW6H	IACT
IODOPROPYNYL BUTYLCARBAMATE	603P14DHEB	IACT
STEARIC ACID	4ELV7Z65AP	IACT
MINERAL OIL	T5L8T28FGP	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
EICOSYL POVIDONE	XQQ9MKE2BJ	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 3 · 135 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TALC	TALC	7SEV7J4R1U	GRANULE, DELAYED RELEASE / ORAL		525 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE, FOR SUSPENSION / ORAL		296 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii+dosage form 3 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / BUCCAL	15 mg		Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	LOTION / TOPICAL		1428 mg	Exact identifier — unii+dosage form 3 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / ORAL	1000 mg		Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE / ORAL		322 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	LOTION / TOPICAL		4000 mg	Exact identifier — unii+dosage form 3 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED / ORAL		87 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE / ORAL		729 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, CHEWABLE / ORAL		202 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	LOTION / TOPICAL		29 mg	Exact identifier — unii+dosage form 3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-	.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE / ORAL		349 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	LOTION / TOPICAL		29 mg	Exact identifier — unii+dosage form 3 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	SUSPENSION, EXTENDED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED PELLETS / ORAL	14 mg		Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	DROPS / ORAL	NA		Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED / ORAL		87 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / RECTAL	32.4 mg		Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE / ORAL		349 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / SUBLINGUAL	32.4 mg		Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	DROPS / ORAL	NA		Exact identifier — unii candidate 105 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii+dosage form 3 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii+dosage form 3 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	PELLET / ORAL		69 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	SUSPENSION / ORAL		234 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	LOTION / TOPICAL		360 mg	Exact identifier — unii+dosage form 3 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	ELIXIR / ORAL	4.5 mg/5ml		Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FOR SUSPENSION / ORAL		24 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	POWDER, FOR SUSPENSION / ORAL		735 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED / ORAL		87 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	SUSPENSION / ORAL		234 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED, EXTENDED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	SUSPENSION, EXTENDED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, CHEWABLE / ORAL		202 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE / ORAL		729 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE / ORAL		729 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / ORAL	1000 mg		Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	DROPS / ORAL	NA		Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	LOZENGE / ORAL		50 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	OINTMENT / TOPICAL	74.6 %w/w		Exact identifier — unii candidate 105 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	LOTION / TOPICAL		4000 mg	Exact identifier — unii+dosage form 3 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, EXTENDED RELEASE / ORAL		300 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	POWDER, FOR SUSPENSION / ORAL		735 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED, EXTENDED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 105 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii+dosage form 3 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / BUCCAL	15 mg		Exact identifier — unii candidate 105 equally ranked IID candidates
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+dosage form 3 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE, FOR SUSPENSION / ORAL		296 mg	Exact identifier — unii candidate 105 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii+dosage form 3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-	.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	AEROSOL, FOAM / TOPICAL	NA		Exact identifier — unii candidate 6 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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRO-TECT SUNSCREEN FOR PROFESSIONALS	MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bio-Medical & Pharmaceutical Manufacturing Corporation	374e172b-90e8-4fca-8934-dee3ed7b599d	2025-12-03	Warnings	Exact identifier ndc (package): 37945-860-64 ndc (package): 37945-860-65 ndc (product): 37945-860 ndc11 (package): 37945086064 ndc11 (package): 37945086065 spl id: 450fca6c-31a2-cde7-e063-6394a90a30c8 spl set id: 374e172b-90e8-4fca-8934-dee3ed7b599d

Reported adverse events (FAERS/openFDA)#

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