Label: COVER-EXPERT SUNSCREEN BROAD SPECTRUM SPF 15 NO.12 WARM COPPER- titanium dioxide, zinc oxide cream
- NDC Code(s): 69879-112-35
- Packager: Luxe Art Beaute SAS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated September 2, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Uses
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
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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
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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
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INGREDIENTS AND APPEARANCE
COVER-EXPERT SUNSCREEN BROAD SPECTRUM SPF 15 NO.12 WARM COPPER
titanium dioxide, zinc oxide creamProduct 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 05/01/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/31/2015 05/01/2025 Labeler - Luxe Art Beaute SAS (378611552)
