INVINCIBLE SETTING POWDER SPF 45 LIGHT- 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.

----------

Invincible Setting Powder SPF 45 Light

Active ingredients      Purpose

Zinc Oxide 24.5%      Sunscreen           

Uses

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

Stop use and ask a doctor if rash occurs

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Directions

Inactive Ingredients

Calcium Aluminum Borosilicate, Silica, Polymethyl Methacrylate, Ethylhexylglycerin, Triethoxycaprylysilane, Nylon-6/12, Sodium Dehydroacetate, Olive Glycerides, Ascorbyl Palmitate, Ceramide 3. May contain +/- Iron Oxides (CI 77492, CI 77491, CI 77499), Titanium Dioxide (CI 77891)

Invincible Setting Powder SPF 45

100% Mineral + Sweat resistant

Light

0.15 oz./ 4.25 g

Secondary

Wrap

INVINCIBLE SETTING POWDER SPF 45 LIGHT 
zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-146
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
CERAMIDE 3 (UNII: 4370DF050B)  
Other Ingredients
Ingredient KindIngredient NameQuantity
May containFERRIC OXIDE RED (UNII: 1K09F3G675)  
May containFERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
May containFERROSOFERRIC OXIDE (UNII: XM0M87F357)  
May containTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-146-021 in 1 BOX01/15/2018
1NDC:75936-146-014.25 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/15/2018
Labeler - TAYLOR JAMES, LTD. (033381850)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Laboratories, Inc.001535103manufacture(75936-146)

Revised: 1/2018
Document Id: 3e05f511-490b-4972-a705-c3184b438ebc
Set id: 4f7109d5-8ac1-419e-a4dc-ec0f45ab273c
Version: 1
Effective Time: 20180115
 
TAYLOR JAMES, LTD.