Total Protector Color 30 Medium Tint

Manufacturer: MD Formulation | Harmony Labs, Inc.
Effective date: 2011-05-25
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:28:06

Label at a glance#

ProductTotal Protector Color 30 Medium Tint

Active ingredientOctinoxate, Zinc Oxide, Octisalate

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Zinc Oxide - 7.8%                   Sunscreen
Octinoxote - 7.5%                     Sunscreen
Octisalate - 4.0%                    Sunscreen

INDICATIONS & USAGE SECTION

When using this product do not use in or near the eyes. If product gets into eyes, rinse thoroughly with water.

WARNINGS SECTION

Warnings For external use only.

OTC - STOP USE SECTION

Stop use and ask a doctor if Irritation of rash appears and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Polson Control Center right away .

INACTIVE INGREDIENT SECTION

Inactive ingredients Purified Waler (Aqua), C 12-15 Alkyl Benzoate, Glyceryl Stearate, Glycerin,Steareth-2, Steareth-100, TricontanylPVP, PEG-100 Stearate, Tocopheryl Acetate, Allantoin, Dimethicone, Xanthan Gum, Cetyl Hydroxyethylcellulose, Disodium EDTA, Diazolidinyl Urea, Iodopropynl Butylcarbamate, Phenoxyethanol, Methylparaben, Propylparaben, Mica(CI 77019), Bismuth Oxychloride (CI 77163), Iron Oxides (CI 77489)

OTC - PURPOSE SECTION

Active Ingredient                        Purpose

Zinc Oxide - 7.8%                     Sunscreen
Octinoxote - 7.5%                     Sunscreen
Octisalate   - 4.0%                     Sunscreen

DOSAGE & ADMINISTRATION SECTION

Directions Children under 2 years of age should use sunscreen products with a minimum SPF of 4. Adults and children 6 months and over; apply liberally 15 minutes before sun or water exposure; reapply after swimming or excessive sweating or anytime after towel drying. Children under 6 months ask a doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66078-504-25	2019-10-29	C162847	48780-1	960f7f55-db47-8e05-e053-dbdaa90a074a	SUN Total Protector Color 30 Medium Tint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66078-504-25	Total Protector Color 30 Medium Tint	42 in 1 CASE	CREAM	42		3
66078-504-25	Total Protector Color 30 Medium Tint	1 in 1 CARTON	CREAM	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66078-504	TOTAL PROTECTOR COLOR 30 MEDIUM TINT (OCTINOXATE) CREAM [MD FORMULATION]	3	Legacy NDC, 2 package rows	20110526_b18dc7a1-a9e7-4f35-a557-d7062613c1e4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	3
Octisalate	ACTIVE INGREDIENT	4X49Y0596W	3
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	3
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	3
Octisalate	ACTIVE MOIETY	4X49Y0596W	3
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	3
.ALPHA.-TOCOPHEROL ACETATE, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	3
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	3
Allantoin	INACTIVE INGREDIENT	344S277G0Z	3
BISMUTH OXYCHLORIDE	INACTIVE INGREDIENT	4ZR792I587	3
BROWN IRON OXIDE	INACTIVE INGREDIENT	1N032N7MFO	3
CETYL HYDROXYETHYLCELLULOSE (350000 MW)	INACTIVE INGREDIENT	T7SWE4S2TT	3
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	3
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	3
Iodopropynyl Butylcarbamate	INACTIVE INGREDIENT	603P14DHEB	3
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	3
Mica	INACTIVE INGREDIENT	V8A1AW0880	3
PEG-100 Stearate	INACTIVE INGREDIENT	YD01N1999R	3
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	3
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	3
Steareth-2	INACTIVE INGREDIENT	V56DFE46J5	3
TRIACONTANYL PVP (WP-660)	INACTIVE INGREDIENT	N0SS3Q238D	3
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	3
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	3

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

Total Protector Color 30 Medium Tint
Octinoxate
Zinc Oxide
Octisalate
Glycerin
Allantoin
EDETATE DISODIUM
Xanthan Gum
CETYL HYDROXYETHYLCELLULOSE (350000 MW)
Methylparaben
GLYCERYL MONOSTEARATE
Steareth-2
PEG-100 Stearate
TRIACONTANYL PVP (WP-660)
ALKYL (C12-15) BENZOATE
.ALPHA.-TOCOPHEROL ACETATE, DL-
Propylparaben
TRIETHOXYCAPRYLYLSILANE
Mica
BISMUTH OXYCHLORIDE
BROWN IRON OXIDE
DIAZOLIDINYL UREA
Iodopropynyl Butylcarbamate
Phenoxyethanol
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66078-504	66078-504-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Octinoxate	4Y5P7MUD51	ACTIB
Zinc Oxide	SOI2LOH54Z	ACTIB
Octisalate	4X49Y0596W	ACTIB
Glycerin	PDC6A3C0OX	IACT
Allantoin	344S277G0Z	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
Xanthan Gum	TTV12P4NEE	IACT
CETYL HYDROXYETHYLCELLULOSE (350000 MW)	T7SWE4S2TT	IACT
Methylparaben	A2I8C7HI9T	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
Steareth-2	V56DFE46J5	IACT
PEG-100 Stearate	YD01N1999R	IACT
TRIACONTANYL PVP (WP-660)	N0SS3Q238D	IACT
ALKYL (C12-15) BENZOATE	A9EJ3J61HQ	IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	IACT
Propylparaben	Z8IX2SC1OH	IACT
TRIETHOXYCAPRYLYLSILANE	LDC331P08E	IACT
Mica	V8A1AW0880	IACT
BISMUTH OXYCHLORIDE	4ZR792I587	IACT
BROWN IRON OXIDE	1N032N7MFO	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
Iodopropynyl Butylcarbamate	603P14DHEB	IACT
Phenoxyethanol	HIE492ZZ3T	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FERROSOFERRIC OXIDE	XM0M87F357	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 7 · 401 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE / ORAL		11 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRADERMAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / NASAL	100 mg/100ml		Exact identifier — unii candidate 77 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / RECTAL		452 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CONCENTRATE / ORAL		12 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TRANSDERMAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, FILM COATED / ORAL	4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / TOPICAL		836 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
BROWN IRON OXIDE	BROWN IRON OXIDE	1N032N7MFO	TABLET, FILM COATED / ORAL	0.2 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	PASTE / ORAL		3822 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 29 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / OPHTHALMIC		2 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAVENOUS		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, COATED / ORAL		1 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS		336 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / ORAL	33.34 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET / ORAL	1.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / INTRAVENOUS	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, EXTENDED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRALESIONAL	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.6 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
Steareth-2	STEARETH-2	V56DFE46J5	OINTMENT / TOPICAL		715 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / IONTOPHORESIS	0.1 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
PEG-100 Stearate	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / TOPICAL		552 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	JELLY / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / EPIDURAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	EMULSION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Steareth-2	STEARETH-2	V56DFE46J5	CREAM / TOPICAL		643 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	DROPS / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	OINTMENT / TOPICAL		258 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	GEL / VAGINAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, DELAYED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 77 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

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
22437a1e-58af-4812-a9c1-17c492077efd			b18dc7a1-a9e7-4f35-a557-d7062613c1e4	2011-05-25	Warnings	Exact identifier spl id: 22437a1e-58af-4812-a9c1-17c492077efd spl set id: b18dc7a1-a9e7-4f35-a557-d7062613c1e4

Reported adverse events (FAERS/openFDA)#

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