COVER-EXPERT SUNSCREEN BROAD SPECTRUM SPF 15 NO.12 WARM COPPER- titanium dioxide, zinc oxide cream

Cover-Expert Sunscreen Broad Spectrum SPF 15 No.12 Warm Copper by

Drug Labeling and Warnings

Cover-Expert Sunscreen Broad Spectrum SPF 15 No.12 Warm Copper by is a Otc medication manufactured, distributed, or labeled by Luxe Art Beaute SAS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Titanium dioxide 5.1%

Zinc oxide 2.8%

Purpose

Sunscreen

Uses

• Help to 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 swallowed, get medical help or contact Poison Control Center right away.

Directions

• Apply liberally 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 invcreases your 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, hats and sunglasses
• Children under 6 months of age: Ask a doctor

Other information

Protect the product in this container from excessive heat and direct sun

Inactive ingredients

water, cyclopentasiloxane, talc, glycerin, cetyl peg/ppg-10/1 dimethicone, imperata (imperata cylindrica) root extract, sodium chloride, benzyl alcohol, triethoxycaprylylsilane, c12-13 alkyl lactate, alumina, sodium dehydroacetate, hydrogen dimethicone, dimethicone/vinyl dimethicone crosspolymer, fragrance, squalane, disteardimonium hectorite, peg-8, aluminum hydroxide, potassium sorbate, dehydroacetic acid, propylene carbonate, carbomer, phenoxyethanol, sodium citrate, citric acid, biotin may contain: ​titanium dioxide, iron oxides

Product Label

INGREDIENTS AND APPEARANCE

COVER-EXPERT SUNSCREEN BROAD SPECTRUM SPF 15 NO.12 WARM COPPER 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69879-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	51 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	28 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TALC (UNII: 7SEV7J4R1U)
GLYCERIN (UNII: PDC6A3C0OX)
IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
DIMETHICONE (UNII: 92RU3N3Y1O)
SQUALANE (UNII: GW89575KF9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BIOTIN (UNII: 6SO6U10H04)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69879-112-35	35 mL in 1 TUBE; Type 0: Not a Combination Product	07/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/31/2015

Labeler - Luxe Art Beaute SAS (378611552)