POOF 100% MINERAL PART POWDER SPF 35- zinc oxide powder

Poof 100% Mineral Part Powder SPF 35 by

Drug Labeling and Warnings

Poof 100% Mineral Part Powder SPF 35 by is a Otc medication manufactured, distributed, or labeled by Supergoop, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Zinc Oxide 24.7 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
• use a water resistant sunscreen if swimming or sweating
• reapply 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 SPF value of 15 or higher and other sun
protection measures including:

limit your time in the sun, especially from 10 a.m. – 2 p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT

Inactive ingredients

Calcium Aluminum Borosilicate, Silica, Trimethylsiloxysiloxysilicate, Calcium Sodium Borosilicate, Polymethyl Methacryate, Lauroyl Lysine, Polyglyceryl-10 Pentaisostearate, Boron Nitride, Triethoxycaprylysilane, Ethylhexylglycerin, Nylon-6/12, Sodium Dehydroacetate, Olive Glycerides, Ascorbyl Palmitate, Ceramide 3, Iron Oxides (CI 77492, 77491, 77499)

PRINCIPAL DISPLAY PANEL

Supergoop!

Poof

100% Mineral powder

SPF 35

Broad Spectrum

Sunscreen SPF 35

For Scalp and Hair

0.71 oz. / 20 g

INGREDIENTS AND APPEARANCE

POOF 100% MINERAL PART POWDER SPF 35 
zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-214
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701)
LAUROYL LYSINE (UNII: 113171Q70B)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CERAMIDE NP (UNII: 4370DF050B)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BORON NITRIDE (UNII: 2U4T60A6YD)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-214-01	20 g in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2020

Labeler - Supergoop, LLC (117061743)