TOTAL PROTECTOR COLOR 30 MEDIUM TINT - octinoxate cream 
MD Formulation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SUN Total Protector Color 30 Medium Tint

Active Ingredient                        Purpose

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

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

Warnings For external use only.

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

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

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)

Active Ingredient                        Purpose

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

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.

Unit Carton
Label
TOTAL PROTECTOR COLOR 30 MEDIUM TINT 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66078-504
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide7.8 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate4.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66078-504-2542 in 1 CASE
11 in 1 CARTON
181 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/28/2005
Labeler - MD Formulation (087008363)
Registrant - Harmony Labs, Inc. (105803274)
Establishment
NameAddressID/FEIBusiness Operations
Harmony Labs, Inc.105803274manufacture, label, pack, relabel, repack

Revised: 5/2011
Document Id: 22437a1e-58af-4812-a9c1-17c492077efd
Set id: b18dc7a1-a9e7-4f35-a557-d7062613c1e4
Version: 3
Effective Time: 20110525
 
MD Formulation