POOF 100% MINERAL PART BROAD SPECTRUM SUNSCREEN SPF 45- 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.

----------

Poof 100% Mineral Part Powder Broad Spectrum Sunscreen SPF 45

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

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)

Poof 100% mineral part Powder

Broad Spectrum Sunscreen SPF 45

For Scalp and hair

0.71 oz, 20 g

Box

primary

POOF 100% MINERAL PART BROAD SPECTRUM SUNSCREEN SPF 45 
zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-300
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-300-0120 g in 1 BOTTLE; Type 0: Not a Combination Product01/22/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/22/2019
Labeler - TAYLOR JAMES, LTD (033381850)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Laboratories, Inc.001535103manufacture(75936-300)

Revised: 1/2019
Document Id: 80251d58-f05a-5be9-e053-2991aa0aa05a
Set id: 80251d58-f059-5be9-e053-2991aa0aa05a
Version: 1
Effective Time: 20190123
 
TAYLOR JAMES, LTD