PRO-TECT EVERYDAY SUNSCREEN SPF 15

Manufacturer: A-Cute Derm, Incorporated | Bio-Medical & Pharmaceutical Manufacturing Corporation
Effective date: 2015-10-28
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:43:56

Label at a glance#

ProductPRO-TECT EVERYDAY SUNSCREEN SPF 15

Active ingredientOCTINOXATE, OXYBENZONE, PADIMATE O

Label structure10 sections

Indications and uses

•Pro-Tect® SPF 15+ Broad-Spectrum UVA & UVB protection. •Helps prevent sunburn. •Retains a SPF of 15+ after 80 minutes of activity in water of perspiring. •Provides high protection against sunburn and tanning. •For skin highly sensitive to sunburn.

Dosage and administration

•Apply liberally and evenly on all exposed areas 20-30 minutes before exposure to the sun and as needed. •Children under 6 months of age: ask a doctor.

Contacts and useful links#

PhoneLabel contact281-835-8051

Websitewww.bio-medicalmanufacturing.com

www.bio-medicalmanufacturing.com

Label contents#

Full prescribing information#

DRUG FACTS

STATEMENT OF IDENTITY SECTION

Pro-Tect® SPF 15+ Sunscreen Broad-Spectrum UVA/UVB Protection & Moisturizing Lotion

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate...........................................................7.5%

Oxybenzone.........................................................2.0%

Padimate O...........................................................5.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

•Pro-Tect® SPF 15+ Broad-Spectrum UVA & UVB protection. •Helps prevent sunburn. •Retains a SPF

of 15+ after 80 minutes of activity in water of perspiring. •Provides high protection against sunburn and

tanning. •For skin highly sensitive to sunburn.

Warnings

WARNINGS SECTION

•External use only. •When using this product, keep out of eyes. •Rinse with water to remove. •Stop use and ask a doctor if rash or irritation develops and lasts. •Do not use if sensitive to any of the ingredients of their related compounds.

Directions

DOSAGE & ADMINISTRATION SECTION

•Apply liberally and evenly on all exposed areas 20-30 minutes before exposure to the sun and as needed.

•Children under 6 months of age: ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Leaf, Benzyl Alcohol, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked),

Cetyl Alcohol, Diazolidinyl Urea, Diethanolamine Cetyl Phospate, dl-Alpha Tocopheryl Acetate,

Iodopropynyl Butylcarbamate, Trolamine, Water.

Other Information

OTHER SAFETY INFORMATION

•Daily usage of Pro-Tect SPF15+ may help reduce the chance of premature aging of the skin due to

overexposure to the sun. •This product provides more than 15 times your natural protection against

sunburn. •Very Water Resistant UVA & UVB Broad-Spectrum Protection. •This product may stain light

colored fabrics if washed with bleach. Wash clothing without bleach to remove safely.

Questions or Comments

OTC - QUESTIONS SECTION

Bio-Medical & Pharm. Mfg. Corp.

4311 South Dr.

Houston, TX 77053-4820

281-835-8051

M-F 8AM-5PM

www.bio-medicalmanufacturing.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4 OZPro-Tect

SPF 15

Sunscreen

4.0 FL. OZ (118.3 gram)

NDC:61619-868-07

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
61619-868-04	2020-01-31	C162847	48780-1	9d75b9d0-fe62-f424-e053-dadaa90a57ce	232cc4ca-790b-2e81-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61619-868-04	PRO-TECT EVERYDAY SUNSCREEN SPF 15	118.3 g in 1 BOTTLE, PLASTIC	LOTION	118.3		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61619-868	PRO-TECT EVERYDAY SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, PADIMATE O) LOTION [A-CUTE DERM, INCORPORATED]	3	Legacy NDC, 1 package rows	20151103_232cc4ca-790b-2e81-e054-00144ff88e88.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	3
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	3
PADIMATE O	ACTIVE INGREDIENT	Z11006CMUZ	3
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	3
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	3
PADIMATE O	ACTIVE MOIETY	Z11006CMUZ	3
.ALPHA.-TOCOPHEROL ACETATE, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	3
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	3
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	809Y72KV36	3
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	3
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	3
DIETHANOLAMINE CETYL PHOSPHATE	INACTIVE INGREDIENT	4UG0316V9S	3
IODOPROPYNYL BUTYLCARBAMATE	INACTIVE INGREDIENT	603P14DHEB	3
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

PRO-TECT EVERYDAY SUNSCREEN SPF 15
Octinoxate, Octisalate, Padimate O
OCTINOXATE
OXYBENZONE
PADIMATE O
ALOE VERA LEAF
BENZYL ALCOHOL
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
CETYL ALCOHOL
DIAZOLIDINYL UREA
DIETHANOLAMINE CETYL PHOSPHATE
.ALPHA.-TOCOPHEROL ACETATE, DL-
IODOPROPYNYL BUTYLCARBAMATE
TROLAMINE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61619-868	61619-868-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
PADIMATE O	Z11006CMUZ	ACTIB
ALOE VERA LEAF	ZY81Z83H0X	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	IACT
CETYL ALCOHOL	936JST6JCN	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
DIETHANOLAMINE CETYL PHOSPHATE	4UG0316V9S	IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	IACT
IODOPROPYNYL BUTYLCARBAMATE	603P14DHEB	IACT
TROLAMINE	9O3K93S3TK	IACT
WATER	059QF0KO0R	IACT

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 · 103 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	EMULSION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	59 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	CREAM, AUGMENTED / TOPICAL		20 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / VAGINAL	0.75 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	144 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SPONGE / TOPICAL	11 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / ENDOTRACHEAL		54 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, COATED / ORAL	0.25 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / INTRAVENOUS		242 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SHAMPOO / TOPICAL	3.7 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL, METERED / TRANSDERMAL		14 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	GEL / TOPICAL		185 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SUBCUTANEOUS		90 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	GEL / TRANSDERMAL		30 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / INTRAVENOUS		400 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRAMUSCULAR		40 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CREAM / VAGINAL	1 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, EMULSION / INTRAVENOUS		45 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / SOFT TISSUE		40 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, METERED / RECTAL	ADJ PH		Exact identifier — unii candidate 22 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / ORAL		100 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SPRAY / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CAPSULE, EXTENDED RELEASE / ORAL	1.23 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / INTRAMUSCULAR		500 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SPRAY, METERED / NASAL	5 mg/1ml		Exact identifier — unii candidate 50 equally ranked IID candidates
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, EXTENDED RELEASE / ORAL		132 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	CREAM / TOPICAL		2 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRA-ARTICULAR	1 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 22 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / INTRAMUSCULAR		54 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	8.4 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	GEL / TOPICAL		150 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, FOAM / TOPICAL	2.6 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRASYNOVIAL		18 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-	.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	AEROSOL, FOAM / TOPICAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	FILM, EXTENDED RELEASE / TRANSDERMAL	38.9 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, EMULSION / SUBCUTANEOUS		225 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRALESIONAL		20 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	GEL / VAGINAL		100 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	LOTION / TOPICAL		4000 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / TOPICAL	2 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	GEL / RECTAL		124 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / AURICULAR (OTIC)	0.9 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / VAGINAL		200 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, EMULSION / INTRAMUSCULAR		225 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	EMULSION / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	POWDER / TOPICAL	0.02 mg/mg		Exact identifier — unii candidate 22 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / AURICULAR (OTIC)	1 %w/v		Exact identifier — unii candidate 20 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
232cc4ca-790c-2e81-e054-00144ff88e88			232cc4ca-790b-2e81-e054-00144ff88e88	2015-10-28	Warnings	Exact identifier spl id: 232cc4ca-790c-2e81-e054-00144ff88e88 spl set id: 232cc4ca-790b-2e81-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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