CC CREAM BROAD SPECTRUM SUNSCREEN SPF 35 FAIR TO LIGHT- titanium dioxide, zinc oxide cream

CC Cream Broad Spectrum Sunscreen SPF 35 Fair to Light by

Drug Labeling and Warnings

CC Cream Broad Spectrum Sunscreen SPF 35 Fair to Light by is a Otc medication manufactured, distributed, or labeled by TAYLOR JAMES LTD, Cosway Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 liberally 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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses

· Children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients Water, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Isododecane, Glycerin, Propanediol, Cetyl Diglyceryl, Tris(Trimethylsiloxy)Silyethyl Dimethicone, 1-2-Hexandiol, Pyrus Malus (Apple) Fruit Extract, Sodium Chloride, Iron Oxides, Triethoxycaprylylsilane, Mica, Hydroxyacetophenone, Silica, Titanium Dioxide, Dimethicone/Vinyl Dimethicone Crosspolymer, Trisodium Ethylenediamine Disuccinate, Chlorphenesin, Tin Oxide, Tocopherol, Chondrus Crispus Extract, Sodium Hyaluronate

PRINCIPAL DISPLAY PANEL

Daily Correct

CC Cream Broad Spectrum SPF 35

Fair/Light

1.6 fl. oz./ 47 ml.

INGREDIENTS AND APPEARANCE

CC CREAM BROAD SPECTRUM SUNSCREEN SPF 35 FAIR TO LIGHT 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISODODECANE (UNII: A8289P68Y2)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
APPLE (UNII: B423VGH5S9)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MICA (UNII: V8A1AW0880)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
CHLORPHENESIN (UNII: I670DAL4SZ)
STANNIC OXIDE (UNII: KM7N50LOS6)
TOCOPHEROL (UNII: R0ZB2556P8)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-202-02	1 in 1 BOX	05/24/2018
1	NDC: 75936-202-01	47 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/11/2018

Labeler - TAYLOR JAMES LTD (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company		620899877	manufacture(75936-202)