SUN TOTAL PROTECTOR COLOR 30 LIGHT TINT- zinc oxide, octisalate, octinoxate cream

Sun Total Protector Color 30 Light Tint by

Drug Labeling and Warnings

Sun Total Protector Color 30 Light Tint by is a Otc medication manufactured, distributed, or labeled by MD Formulations, Harmony Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

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

WHEN USING

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

INDICATIONS & USAGE

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

WARNINGS

Warnings : For external use only.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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

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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUN TOTAL PROTECTOR COLOR 30 LIGHT TINT 
zinc oxide, octisalate, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66078-503
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	7.8 mL  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	4 mL  in 100 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66078-503-25	42 in 1 CASE
1		1 in 1 CARTON
1		75 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/20/2007

Labeler - MD Formulations (087008363)

Registrant - Harmony Labs, Inc. (105803274)

Establishment
Name	Address	ID/FEI	Business Operations
Harmony Labs, Inc.		105803274	manufacture, label, pack, relabel, repack