COVER-EXPERT SUNSCREEN BROAD SPECTRUM SPF 15 NO.5 PEACH BEIGE- titanium dioxide, zinc oxide cream
Luxe Art Beaute SAS

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Cover-Expert Sunscreen Broad Spectrum SPF 15 No.5 Peach Beige

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

COVER-EXPERT SUNSCREEN BROAD SPECTRUM SPF 15 NO.5 PEACH BEIGE
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69879-105
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69879-105-35	35 mL in 1 TUBE; Type 0: Not a Combination Product	07/31/2015	08/21/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/31/2015	08/21/2023

Labeler - Luxe Art Beaute SAS (378611552)

Revised: 9/2023

Document Id: 045f3ca6-c95c-2cbb-e063-6394a90a9d23

Set id: 13865a13-2767-4b9f-a46c-77f7298a6ba5

Version: 6

Effective Time: 20230902

Luxe Art Beaute SAS