POOF 100% MINERAL PART BROAD SPECTRUM SUNSCREEN SPF 45- zinc oxide powder

Poof 100% Mineral Part Broad Spectrum Sunscreen SPF 45 by

Drug Labeling and Warnings

Poof 100% Mineral Part Broad Spectrum Sunscreen 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

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 at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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 protection measures including:
• Limit time in the sun ftom 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Poof 100% mineral part Powder

Broad Spectrum Sunscreen SPF 45

For Scalp and hair

0.71 oz, 20 g

INGREDIENTS AND APPEARANCE

POOF 100% MINERAL PART BROAD SPECTRUM SUNSCREEN SPF 45 
zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-300
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
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CERAMIDE NP (UNII: 4370DF050B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-300-01	20 g in 1 BOTTLE; Type 0: Not a Combination Product	01/22/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/22/2019

Labeler - TAYLOR JAMES, LTD (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Laboratories, Inc.		001535103	manufacture(75936-300)