COVERGIRL ADVANCED RADIANCE AGE DEFYING MAKEUP PLUS SUNSCREEN SPF 10 (ALL SHADES)- octinoxate and titanium dioxide liquid

Covergirl Advanced Radiance by

Drug Labeling and Warnings

Covergirl Advanced Radiance by is a Otc medication manufactured, distributed, or labeled by Noxell. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate 2%
Titanium Dioxide 5%

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging

• 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.

• Stop use and ask a doctor if rash occurs.

• Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use water resistant sunscreen if swimming or sweating
• children under 6 months: ask a doctor.

Other information

• protect this product from excessive heat and direct sun

Inactive ingredients

Cyclopentasiloxane, water/eau, glycerin, dimethicone crosspolymer, sodium chloride, niacinamide, diethylhexyl carbonate, talc, peg/ppg-18/18 dimethicone, dimethicone, panthenol, tocopheryl acetate, methicone, aluminum hydroxide, benzyl alcohol, ethylparaben, allantoin, hydrogen dimethicone, peg-10 dimethicone crosspolymer, methylparaben, disodium edta, propylparaben, fragrance/parfum, camellia sinensis leaf extract, titanium dioxide, iron oxides

Questions?

Call 1-800-426-8374

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

105
ivory

OLAY®
INGREDIENTS

COVERGIRL

ADVANCED RADIANCE ®

age defying
makeup
+ sunscreen
SPF 10

DIN 02267543
30 ml (1 fl oz)

INGREDIENTS AND APPEARANCE

COVERGIRL ADVANCED RADIANCE   AGE DEFYING MAKEUP PLUS SUNSCREEN SPF 10 (ALL SHADES)
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 22700-098
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	20 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
NIACINAMIDE (UNII: 25X51I8RD4)
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)
TALC (UNII: 7SEV7J4R1U)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DIMETHICONE (UNII: 92RU3N3Y1O)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
METHICONE (20 CST) (UNII: 6777U11MKT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ETHYLPARABEN (UNII: 14255EXE39)
ALLANTOIN (UNII: 344S277G0Z)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 22700-098-30	1 in 1 CARTON	08/01/2012
1		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2012

Labeler - Noxell (003082997)

Establishment
Name	Address	ID/FEI	Business Operations
Noxell		003082997	manufacture(22700-098) , pack(22700-098)