INVINCIBLE SETTING POWDER SPF 45 DEEP- zinc oxide powder

Invincible Setting Powder SPF 45 Deep by

Drug Labeling and Warnings

Invincible Setting Powder SPF 45 Deep 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

Zinc Oxide 24.5%      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.  If product is swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions

• apply generously and evenly 15 minutes before sun exposure

• reapply 
• after 40 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun Protection Measures ​Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum value of 15 or higher and other sun protections measures including:
• Limit time in the sun, especially from 10a.m. -2p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor

INACTIVE INGREDIENT

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)

PRINCIPAL DISPLAY PANEL

Invincible Setting Powder SPF 45

100% Mineral + Sweat resistant

Deep

0.15 oz./ 4.25 g

INGREDIENTS AND APPEARANCE

INVINCIBLE SETTING POWDER SPF 45 DEEP 
zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-148
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Kind	Ingredient Name	Quantity
May contain	FERRIC OXIDE RED (UNII: 1K09F3G675)
May contain	FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
May contain	FERROSOFERRIC OXIDE (UNII: XM0M87F357)
May contain	TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-148-02	1 in 1 BOX	01/15/2018
1	NDC: 75936-148-01	4.25 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/15/2018

Labeler - TAYLOR JAMES, LTD. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Laboratories, Inc.		001535103	manufacture(75936-148)