SHIMMERSHADE BROAD SPECTRUM SPF 30 FIRST LIGHT- octisalate, zinc oxide cream

Shimmershade Broad Spectrum SPF 30 First Light by

Drug Labeling and Warnings

Shimmershade Broad Spectrum SPF 30 First Light 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

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 Sunscreen SPF 30

First Light

0.18 oz. /5 g

INGREDIENTS AND APPEARANCE

SHIMMERSHADE BROAD SPECTRUM SPF 30 FIRST LIGHT 
octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-301
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
ISODODECANE (UNII: A8289P68Y2)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
STANNIC OXIDE (UNII: KM7N50LOS6)
.DELTA.-TOCOPHEROL (UNII: JU84X1II0N)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-301-01	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	01/23/2019

Labeler - TAYLOR JAMES, LTD. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company Inc.		620899877	manufacture(75936-301)