MINERAL SHEER SCREEN BROAD SPECTRUM SUNSCREEN SPF 30- zinc oxide lotion

Mineral Sheer Screen Broad Spectrum Sunscreen SPF 30 by

Drug Labeling and Warnings

Mineral Sheer Screen Broad Spectrum Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Supergoop LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient Purpose

Zinc Oxide 17.5% 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 againg 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

For external use only

Do not use on damaged or broken skin

When using this product kee 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

Water, Isododecane, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Propanedlol, Glycerin, Squalane, Trioctyldodecyl Citrate, Polyglycerln-3, Polyglyceryl-3 Lactate/Laurate, Polysilicone-11, Cetearyl Alcohol, Glyceryl Stearate, Sodium Stearoyl Glutamate, Butylene Glycol, Xanthan Gum, Polyacrylate Crosspolymer-6, lsostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Caprylhydroxamic Acid, Citric Acid, Aloe Barbadensis Leaf Juice, Lespedeza Capitata Leaf/Stem Extract, Maltodextrin, Sodium Hyaluronate

STORAGE AND HANDLING

Protect the product In this container from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

Mineral Sheer Screen

SPF 30

100% Mineral

Broad Spectrum Sunscreen

SPF 30 PA+++

1.5 fl. oz./45 ml

INGREDIENTS AND APPEARANCE

MINERAL SHEER SCREEN BROAD SPECTRUM SUNSCREEN SPF 30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-305
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	17.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PROPANEDIOL (UNII: 5965N8W85T)
SQUALANE (UNII: GW89575KF9)
ISOSTEARIC ACID (UNII: X33R8U0062)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-305-01	45 mL in 1 TUBE; Type 0: Not a Combination Product	01/12/2021
2	NDC: 75936-305-02	15 mL in 1 TUBE; Type 0: Not a Combination Product	01/12/2021
3	NDC: 75936-305-03	10 mL in 1 TUBE; Type 0: Not a Combination Product	01/12/2021
4	NDC: 75936-305-04	5 mL in 1 TUBE; Type 0: Not a Combination Product	01/12/2021
5	NDC: 75936-305-05	20 mL in 1 TUBE; Type 0: Not a Combination Product	08/26/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/12/2021

Labeler - Supergoop LLC (117061743)