Sun Total Protector Color 30 Dark Tint

Manufacturer: MD Formulations | Harmony Labs, Inc.
Effective date: 2010-08-16
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:25:34

Label at a glance#

ProductSun Total Protector Color 30 Dark Tint

Active ingredientZinc Oxide, Octisalate, Octinoxate

Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide - 7.8%
Octlnoxote - 7.5%
Octlsolote - 4.0%

OTC - PURPOSE SECTION

Zinc Oxide - 7.8%   Sunscreen
Octlnoxote - 7.5%   Sunscreen
Octlsolote - 4.0%   Sunscreen

OTC - WHEN USING SECTION

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

INDICATIONS & USAGE SECTION

Uses to help prevent sunburn and for the temporary protection of sunburn.

WARNINGS SECTION

Warnings : For external use only.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Polson Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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.

SPL UNCLASSIFIED SECTION

Other information Store at 20-25C (68 - 77F) Sun Alert: The sun causes sun damage. Regular use of sunscreens over the years may reduce the chance of skin damage, some types of skin cancer, and other harmful effects due to the sun.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Purified Water (Aqua), C12-15 Alkyl Benzoate, Glyceryl Stearate, Glycerin, Stearelh·2, Stearelh-100, Trlcontanyl PVP, PEG-100 stearate, Tocopheryl Acetate, Allontoln, Dlmethlcone, Xanthun Gum, Cetyl Hydroxyethylcellulose, Disodium EDTA, Dlazolldlnyl Urea, lodopropynl Butylcarbamate, Methyldlbromo Glutaronllrlle, Phenoxyethcnol, Methylparaben, Propylparaben, MIca (CI 77019), Blsmulh OxychlorIde (CI 77163), Iron Oxides (CI77489)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66078-505-25	2019-10-21	C162847	48780-1	956f9ecf-c68a-621f-e053-dbdaa90a74ad	Total Protector Color 30 dark tint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66078-505-25	Sun Total Protector Color 30 Dark Tint	1 in 1 CARTON	CREAM	1		1
66078-505-25	Sun Total Protector Color 30 Dark Tint	42 in 1 CASE	CREAM	42		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66078-505	SUN TOTAL PROTECTOR COLOR 30 DARK TINT CREAM [MD FORMULATIONS]	1	Legacy NDC, 2 package rows	20100817_e6ffc752-9f70-47a8-b639-ae995eec0b8a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	1
Octisalate	ACTIVE INGREDIENT	4X49Y0596W	1
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	1
Octisalate	ACTIVE MOIETY	4X49Y0596W	1
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

Sun Total Protector Color 30 Dark Tint
Zinc Oxide
Octisalate
Octinoxate

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66078-505	66078-505-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Zinc Oxide	SOI2LOH54Z	ACTIB
Octisalate	4X49Y0596W	ACTIB
Octinoxate	4Y5P7MUD51	ACTIB

Source Document#

Source XML

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
e95e2ede-4887-4900-ae8d-a1b8a1b9ec62			e6ffc752-9f70-47a8-b639-ae995eec0b8a	2010-08-16	Warnings	Exact identifier spl id: e95e2ede-4887-4900-ae8d-a1b8a1b9ec62 spl set id: e6ffc752-9f70-47a8-b639-ae995eec0b8a

Reported adverse events (FAERS/openFDA)#

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