CC DAILY CORRECT BROAD SPECTRUM SPF 35 SUNSCREEN MEDIUM TO DARK SUPERGOOP- titanium dioxide, zinc oxide cream

CC Daily Correct Broad Spectrum SPF 35 Sunscreen Medium to Dark by

Drug Labeling and Warnings

CC Daily Correct Broad Spectrum SPF 35 Sunscreen Medium to Dark by is a Otc medication manufactured, distributed, or labeled by TAYLOR JAMES, LTD., Cosway Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients purpose

Titanium Dioxide 1.42 % 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

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

If swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Directions Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

Children under 6 months: Ask a doctor

Sun Protection Measures Spending time in the sun increases your skin 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, pants hats and sunglasses

INACTIVE INGREDIENT

Inactive Ingredients Water, Cyclopentasiloxane, Propanediol, Dimethicone, Iron Oxides, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Mica, Sodium Chloride, Pyrus Malus (apple) Fruit Extract, Phenoxyethanol, Glycerin, Dimethicone/PEG-10/15 Crosspolymer, Titanium Dioxide, Triethoxycaprylylsilane, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Chondrus Crispus Extract, Tetrasodium EDTA, Hydrolyzed Chondrus Crispus Extract, Methylisothiazolinone, Tin Oxide, Sodium Hyaluronate.

PRINCIPAL DISPLAY PANEL

CC cream Daily Correct Broad Spectrum SPF 35 Sunscreen

Medium to Dark

Self-Adjusting Shade

PA +++

Supergoop

Paraben, Fragrance, and Oxybenzone Free

1.6 fl. oz. / 47

INGREDIENTS AND APPEARANCE

CC DAILY CORRECT BROAD SPECTRUM SPF 35 SUNSCREEN MEDIUM TO DARK  SUPERGOOP
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-122
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.42 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPANEDIOL (UNII: 5965N8W85T)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
APPLE (UNII: B423VGH5S9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
STANNIC OXIDE (UNII: KM7N50LOS6)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-122-02	1 in 1 CARTON	01/07/2013
1	NDC: 75936-122-01	47 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 75936-122-04	3 mL in 1 TUBE; Type 0: Not a Combination Product	01/07/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/07/2013

Labeler - TAYLOR JAMES, LTD. (033381850)

Registrant - TAYLOR JAMES, LTD. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company Inc		620899877	manufacture(75936-122)