ZINC SCREEN BROAD SPECTRUM SUNSCREEN SPF 40- zinc oxide lotion

Zinc Screen Broad Spectrum Sunscreen SPF 40 by

Drug Labeling and Warnings

Zinc Screen Broad Spectrum Sunscreen SPF 40 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

Zinc Oxide 13% 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 or irritation develops and lasts.

WARNINGS

Warnings

Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove
For external use only

DOSAGE & ADMINISTRATION

Directions

Apply generously and evenly 15 minutes before sun exposure
Use a water-resistant sunscreen if swimming or sweating
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 measures including: limit your time in the sun, especially from 10
a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses
Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT

Inactive Ingredients

Water, Tetradecane, Cetearyl Nonanoate, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Isopropyl Myristate, Glycerin, Polyglyceryl-3 Diisostearate, Mica, Propanediol, Disteardimonium Hectorite, Gluconolactone, Polyglyceryl-6 Polyricinoleate, Brassica Campestris/Aleurites Fordi Oil Copolymer, Polyhydrostearic Acid, Sodium Chloride, Magnesium Sulfate, Fructose, Octyldodecyl Oleate, Tocopherol, Cocos Nucifera (Coconut) Fruit Extract, Sodium Benzoate, Iron oxides (CI 77492), Dodecane, Hexadecane, Titanium Dioxide (CI 77891), Withania Somnifera Flower Extract, Iron Oxides (CI 77491), Vaccinium Angustifolia (Blueberry) Fruit Extract, Silica, Calcium Gluconate

PRINCIPAL DISPLAY PANEL

Zinc Screen

100% Mineral Lotion

Broad Spectrum SPF 40 PA+++

1.7 fl. oz. / 50 ml.

INGREDIENTS AND APPEARANCE

ZINC SCREEN BROAD SPECTRUM SUNSCREEN SPF 40 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-223
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLUCONOLACTONE (UNII: WQ29KQ9POT)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PROPANEDIOL (UNII: 5965N8W85T)
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
TETRADECANE (UNII: 03LY784Y58)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
WATER (UNII: 059QF0KO0R)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082)
HEXADECANE (UNII: F8Z00SHP6Q)
CETEARYL NONANOATE (UNII: F6ZWV2F361)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERIN (UNII: PDC6A3C0OX)
COCONUT (UNII: 3RT3536DHY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
DODECANE (UNII: 11A386X1QH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
FRUCTOSE (UNII: 6YSS42VSEV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-223-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/30/2019

Labeler - Taylor James Ltd. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Northwest Cosmetic Labs		929572014	manufacture(75936-223)