CC SCREEN 100% MINERAL CC CREAM BROAD SPECTRUM SPF 50 416W- titanium dioxide, zinc oxide cream

CC Screen 100% Mineral CC Cream Broad Spectrum SPF 50 416W by

Drug Labeling and Warnings

CC Screen 100% Mineral CC Cream Broad Spectrum SPF 50 416W 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

Titanium Dioxide 4% 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
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, Iron Oxides, C12-15 Alkyl Benzonate, Butyoctyl Salicylate, Isododecane, Propanediol, Glycerin, Cetyl Diglyceryl Tris(Trimethylsiloxy) siloxysilylethyl Dimethicone, 1,2-Hexanediol, Pyrus Malus (Apple) Fruit Extract, Sodium Chloride, Silica, Triethoxycaprylylsilane, Dimethicone/Vinyl Dimethicone Crosspolymer, Mica, Hydroxyacetophenone, Titanium Dioxide, Diethylhexyl Syringylidenemalonate, Trisodium Ethylenediamine Dissucinate, Chlorphenesin, Xanthan Gum, Chondrus Crispus Extract, Caprylic/Capric Triglyceride, Tin Oxide, Sodium Hyaluronate, Tocopherol

PRINCIPAL DISPLAY PANEL

CC screen 100% Mineral CC Cream 416W

SPF 50

Broad Spectrum Sunscreen SPF 50 PA+++

1.6 fl. oz. / 47 ml.

INGREDIENTS AND APPEARANCE

CC SCREEN 100% MINERAL CC CREAM BROAD SPECTRUM SPF 50 416W 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-238
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 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ISODODECANE (UNII: A8289P68Y2)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STANNIC OXIDE (UNII: KM7N50LOS6)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PROPANEDIOL (UNII: 5965N8W85T)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
APPLE (UNII: B423VGH5S9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
CHLORPHENESIN (UNII: I670DAL4SZ)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-238-01	47 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/28/2020

Labeler - Supergoop, LLC (117061743)