FDA.reportPublic FDA data

Sun Total Protector Color 30 Light Tint

Manufacturer
MD Formulations | Harmony Labs, Inc.
Effective date
2010-08-17
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 Light Tint
Active ingredientZinc Oxide, Octisalate, Octinoxate
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Zinc Oxide - 7.8%   Sunscreen
Octlnoxate - 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 Poison 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: Water (Aqua), C12-15 Alkyl Benzoate, Glyceryl Stearate, Glycerin, Stearelh·2, Stearelh-100, Trlcontanyl PVP, PEG-100 stearate, Tocopheryl Acetate, Allantoin, Dimethicone, Xanthan Gum, Cetyl Hydroxyethylcellulose, Disodium EDTA, Diazolidinyl Urea, lodopropynl Butylcarbamate, Methyldibromo Glutaronitrile, Phenoxyethanol, Methylparaben, Propylparaben, MIca (CI 77019), Blsmuth OxychlorIde (CI 77163), Iron Oxides (CI77489)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label
Label
Unit Carton
Unit Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66078-503-252019-10-21C16284748780-1956f9ecf-dd4f-621f-e053-dbdaa90a74adTotal Protector Color 30 light tint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66078-503-25Sun Total Protector Color 30 Light Tint1 in 1 CARTONCREAM11
66078-503-25Sun Total Protector Color 30 Light Tint42 in 1 CASECREAM421

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66078-503SUN TOTAL PROTECTOR COLOR 30 LIGHT TINT (ZINC OXIDE, OCTISALATE, OCTINOXATE) CREAM [MD FORMULATIONS]1Legacy NDC, 2 package rows20100818_e3956a48-4055-4520-a0c3-c54d36df84e0.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
OctisalateACTIVE INGREDIENT4X49Y0596W1
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
OctinoxateACTIVE MOIETY4Y5P7MUD511
OctisalateACTIVE MOIETY4X49Y0596W1
Zinc OxideACTIVE MOIETYSOI2LOH54Z1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66078-50366078-503-25

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
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
Octisalate4X49Y0596WACTIB
Octinoxate4Y5P7MUD51ACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a6cc9a25-ad18-4d07-8efa-8ef185552e6fe3956a48-4055-4520-a0c3-c54d36df84e02010-08-17WarningsExact identifier
spl id: a6cc9a25-ad18-4d07-8efa-8ef185552e6f
spl set id: e3956a48-4055-4520-a0c3-c54d36df84e0

Reported adverse events (FAERS/openFDA)#

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