(RE) SETTING 100% MINERAL POWDER TRANSLUCENT BROAD SPECTRUM SUNSCREEN SPF 35- zinc oxide powder

(RE) Setting 100% Mineral Powder Translucent Broad Spectrum Sunscreen SPF 35 by

Drug Labeling and Warnings

(RE) Setting 100% Mineral Powder Translucent Broad Spectrum Sunscreen SPF 35 by is a Otc medication manufactured, distributed, or labeled by Supergoop, LLC, Port Jervis Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 24.7% Purpose Sunscreen

PURPOSE

• Sunscreen
• 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 swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

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 products keep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION

• 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 SPF value of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglassess
• Children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Calcium Aluminum Borosilicate, Silica, Trimethylsiloxysilicate, Calcium Sodium Borosilicate, Polymethyl Methacrylate, 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!

(RE) SETTING

100% Mineral Powder

SPF 35

Translucent

Broad Spectrum Sunscreen SPF 35 PA+++

0.15 oz./4.25 g

INGREDIENTS AND APPEARANCE

(RE) SETTING 100% MINERAL POWDER TRANSLUCENT BROAD SPECTRUM SUNSCREEN SPF 35 
zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-169
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
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LAUROYL LYSINE (UNII: 113171Q70B)
BORON NITRIDE (UNII: 2U4T60A6YD)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
CERAMIDE 3 (UNII: 4370DF050B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-169-01	4.25 g in 1 BOTTLE; Type 0: Not a Combination Product	09/08/2020
2	NDC: 75936-169-02	4.25 g in 1 JAR; Type 0: Not a Combination Product	09/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/08/2020

Labeler - Supergoop, LLC (117061743)

Establishment
Name	Address	ID/FEI	Business Operations
Port Jervis Laboratories, Inc		001535103	manufacture(75936-169)