TOTAL PROTECTOR COLOR 30 MEDIUM TINT- octinoxate cream

Total Protector Color 30 Medium Tint by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                        Purpose

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

INDICATIONS & USAGE

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

WARNINGS

Warnings For external use only.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

INACTIVE INGREDIENT

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)

PURPOSE

Active Ingredient                        Purpose

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

DOSAGE & ADMINISTRATION

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOTAL PROTECTOR COLOR 30 MEDIUM TINT 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66078-504
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	7.8 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	4.0 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66078-504-25	42 in 1 CASE
1		1 in 1 CARTON
1		81 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/28/2005

Labeler - MD Formulation (087008363)

Registrant - Harmony Labs, Inc. (105803274)

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