COVERGIRL AQUASMOOTH BROADSPECTRUM SPF 20 ALL SHADES- titanium dioxide cream

Covergirl Aquasmooth by

Drug Labeling and Warnings

Covergirl Aquasmooth by is a Otc medication manufactured, distributed, or labeled by Noxell Corporation, COTY US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Titanium Dioxide 9%

Purpose

Sunscreen

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

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.

• 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
• 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 time in sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
• children under 6 months: ask a doctor

Other information

• protect this product from excessive heat and direct sun

Inactive ingredients

Cyclopentasiloxane, water, butylene glycol, silica, niacinamide, tridecyl isononanoate, sorbitan isostearate, talc, euphorbia cerifera (candelilla) wax, ozokerite, tocopheryl acetate, panthenol, tocopherol, peg/ppg-18/18 dimethicone, dimethicone, phenoxyethanol, methicone, stearic acid, disodium edta, hydroxypropyl cyclodextrin, iodopropynyl butylcarbamate, sodium acetate, aluminum hydroxide, mica, titanium dioxide, iron oxides.

Questions?

Call 1-800-426-8374

PRINCIPAL DISPLAY PANEL - 12 g Case Blister Pack

aqua smooth ®

makeup+
titanium dioxide sunscreen
broad spectrum SPF 20

705
ivory

COVERGIRL

Solid makeup that transforms into liquid for smooth coverage

12 g (.4 oz)

INGREDIENTS AND APPEARANCE

COVERGIRL AQUASMOOTH   BROADSPECTRUM SPF 20 ALL SHADES
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 22700-084
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NIACINAMIDE (UNII: 25X51I8RD4)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
CANDELILLA WAX (UNII: WL0328HX19)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
TOCOPHEROL (UNII: R0ZB2556P8)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
SODIUM ACETATE (UNII: 4550K0SC9B)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 22700-084-12	1 in 1 BLISTER PACK	03/15/2014
1		12 g in 1 CASE; 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	03/15/2014

Labeler - Noxell Corporation (003082997)

Registrant - COTY US LLC (039056361)

Establishment
Name	Address	ID/FEI	Business Operations
Noxell Corporation		003082997	manufacture(22700-084)