INVINCIBLE SETTING POWDER SPF 45- titanium dioxide, zinc oxide powder 
TAYLOR JAMES, LTD.

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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Invincible Setting Powder SPF 45

Active ingredients                 Purpose

Titanium Dioxide 15.7%        Sunscreen

Zinc Oxide 20%                    Sunscreen

Uses ​Helps Prevent sunburn

If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun

Keep out of reach of children

Stop use and ask a doctor if rash occurs

Warnings For external use only

Do not on damaged or broken skin

When using this product keep out of eyes

Rinse with water to remove

If swallowed, get medical help or contact a Poison Center right away

Directions ​Apply liberally and evenly to face before sun exposure 

Reapply after 40 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

Children under 6 months: Ask a doctor

Inactive Ingredients  ​Silica, Calcium Aluminum Borosilicate, Polymethyl Methacrylate, Lauroyl Lysine, Phenoxyethanol,  Water (Aqua), Sodium Dehydroacetate, Ascorbyl palmitate, Ceteareth-25, Glycerin, Cetyl Alcohol, Cholesterol, Ceramide NP, Behenic Acid, Ethylhexyglycerin, Ceramide NS, Ceramide AP, Ceramide EOP, Ceramide EOS, Caprooyl Pytosphingosine, Caprooyl Sphingosine, Tocopherol, Titanium Dioxide (CI77891), Iron Oxides (CI 77491)

Invincible Setting Powder

SPF 45

100% mineral. Sweat Resistant

0.09 oz / 2.5 g

outer

jar

INVINCIBLE SETTING POWDER SPF 45 
titanium dioxide, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE15.7 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
LAUROYL LYSINE (UNII: 113171Q70B)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
CETEARETH-25 (UNII: 8FA93U5T67)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
CERAMIDE NP (UNII: 4370DF050B)  
BEHENIC ACID (UNII: H390488X0A)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CERAMIDE NG (UNII: C04977SRJ5)  
Ceramide AP (UNII: F1X8L2B00J)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
N-HEXANOYLSPHINGOSINE (UNII: 038753E78J)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-105-014.5 g in 1 PACKAGE; Type 0: Not a Combination Product01/13/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/13/2017
Labeler - TAYLOR JAMES, LTD. (033381850)
Registrant - TAYLOR JAMES, LTD. (033381850)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Laboratories, Inc.001535103manufacture(75936-105)

Revised: 1/2017
Document Id: 344ebfe9-7ead-48ac-8fbc-ec8c2ad6e98c
Set id: 717ea2fc-b739-4378-8724-21f6bd835333
Version: 1
Effective Time: 20170113
 
TAYLOR JAMES, LTD.