SHIMMERSHADE BROAD SPECTRUM SUNSCREEN SPF 30 SUNSET- octisalate, zinc oxide cream SHIMMERSHADE BROAD SPECTRUM SUNSCREEN SPF 30 GOLDEN HOUR- octisalate, zinc oxide cream SHIMMERSHADE BROAD SPECTRUM SUNSCREEN SPF 30 DAY DREAM- octisalate, zinc oxide cream

Shimmershade Broad Spectrum Sunscreen SPF 30 Sunset by

Drug Labeling and Warnings

Shimmershade Broad Spectrum Sunscreen SPF 30 Sunset by is a Otc medication manufactured, distributed, or labeled by Supergoop, LLC, Cosway Company, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Octisalate 5% Sunscreen

Zinc Oxide 20% 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
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 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 sunglasses
Children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients

Isododecane, Mica, Titanium Dioxide, Polymethylsilsesquioxane/Silica Crosspolymer, Polyethylene,
Caprylyl Methicone, Iron oxides, C18-38 Alkyl Hydroxystearoyl Stearate, Polyhydroxystearic Acid,
Dimethicone, Trimethylsiloxysilicate, Silica, VP/Eicosene Copolymer, Polyglyceryl-3 Polyricinoleate,
Polyglyceryl-3 Diisostearate,Triethoxycaprylylsilane, Norbornene/tris(trimethylsiloxy)silyl-norbornene
Copolymer, Tin Oxide, Helianthuus Annuus (Sunflower) Seed Oil, Jasminum Officinale (Jasmine) Flower
Extract, Rose Extract, Tocopherol.

PRINCIPAL DISPLAY PANEL

Shimmershade

Broad Spectrum SPF 30

Golden Hour

Supergoop

0.18 oz./5 g

INGREDIENTS AND APPEARANCE

SHIMMERSHADE BROAD SPECTRUM SUNSCREEN SPF 30 SUNSET 
octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-304
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
.DELTA.-TOCOPHEROL (UNII: JU84X1II0N)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
DIMETHICONE (UNII: 92RU3N3Y1O)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ISODODECANE (UNII: A8289P68Y2)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-304-01	5 g in 1 JAR; Type 0: Not a Combination Product	01/24/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/24/2019

SHIMMERSHADE BROAD SPECTRUM SUNSCREEN SPF 30 GOLDEN HOUR 
octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
.DELTA.-TOCOPHEROL (UNII: JU84X1II0N)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
DIMETHICONE (UNII: 92RU3N3Y1O)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ISODODECANE (UNII: A8289P68Y2)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-302-01	5 g in 1 JAR; Type 0: Not a Combination Product	01/24/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/24/2019

SHIMMERSHADE BROAD SPECTRUM SUNSCREEN SPF 30 DAY DREAM 
octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
.DELTA.-TOCOPHEROL (UNII: JU84X1II0N)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
DIMETHICONE (UNII: 92RU3N3Y1O)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ISODODECANE (UNII: A8289P68Y2)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-303-01	5 g in 1 JAR; Type 0: Not a Combination Product	01/24/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/24/2019

Labeler - Taylor James Ltd (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company, Inc		620899877	manufacture(75936-302, 75936-303, 75936-304)