INVINCIBLE SETTING POWDER SPF 45- titanium dioxide, zinc oxide powder

Invincible Setting powder SPF 45 by

Drug Labeling and Warnings

Invincible Setting powder SPF 45 by is a Otc medication manufactured, distributed, or labeled by TAYLOR JAMES, LTD., Kolmar Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                 Purpose

Titanium Dioxide 15.7%        Sunscreen

Zinc Oxide 20%                    Sunscreen

PURPOSE

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

Keep out of reach of children

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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)

PRINCIPAL DISPLAY PANEL

Invincible Setting Powder

SPF 45

100% mineral. Sweat Resistant

0.09 oz / 2.5 g

INGREDIENTS AND APPEARANCE

INVINCIBLE SETTING POWDER SPF 45 
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	15.7 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-105-01	4.5 g in 1 PACKAGE; Type 0: Not a Combination Product	01/13/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/13/2017

Labeler - TAYLOR JAMES, LTD. (033381850)

Registrant - TAYLOR JAMES, LTD. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Laboratories, Inc.		001535103	manufacture(75936-105)