NDC | 69879-108-35 |
Set ID | 6fb83041-2e0c-4336-8065-10914354db2f |
Category | HUMAN OTC DRUG LABEL |
Packager | Luxe Art Beaute SAS |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- 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
LUXE ART BEAUTE SAS (69879-108-35) COVER-EXPERT SUNSCREEN BROAD SPECTRUM SPF 15 NO.8 INTENSE BEIGE, 35ML
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69879-108 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BIOTIN (UNII: 6SO6U10H04) DEHYDROACETIC ACID (UNII: 2KAG279R6R) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM CITRATE (UNII: 1Q73Q2JULR) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69879-108-35 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)