![UV ESSENTIEL COMPLETE PROTECTION ANTIOXIDANT ANTI-POLLUTION SUNSCREEN BROAD SPECTRUM SPF 50 (OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE) EMULSION [CHANEL PARFUMS BEAUTE]](https://medic.hrt.org//dailymed/images/58c8b496-885b-47b3-b9e7-3fd8ae55a471/uv-essentiel-01.jpg)
| NDC | 68745-2116-1 |
| Set ID | 58c8b496-885b-47b3-b9e7-3fd8ae55a471 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | CHANEL PARFUMS BEAUTE |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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Directions
- For sunscreen use:
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
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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 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
- For sunscreen use:
- Other information
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Inactive ingredients
water • butylene glycol dicaprylate/dicaprate • alcohol • caprylyl methicone • glycerin • polymethylsilsesquioxane • lauryl PEG-9 polydimethylsiloxyethyl dimethicone • yeast extract • kalanchoe pinnata leaf extract • glycyrrhiza glabra (licorice) root extract • diethylhexyl syringylidenemalonate • triethoxycaprylylsilane • hydrogenated polyisobutene • aluminum hydroxide • stearic acid • fragrance • butylene glycol • caprylyl glycol • dimethicone • ectoin • phenoxyethanol • caprylic/capric triglyceride • disteardimonium hectorite • propylene carbonate • sodium hyaluronate • BHT • 1,2-hexanediol • maltodextrin • tocopherol
il28A - Questions or comments?
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
UV ESSENTIEL COMPLETE PROTECTION ANTIOXIDANT ANTI-POLLUTION SUNSCREEN BROAD SPECTRUM SPF 50
octinoxate, titanium dioxide, and zinc oxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68745-2116 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 38 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 171 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) butylene glycol dicaprylate/dicaprate (UNII: 75D21FL1PI) alcohol (UNII: 3K9958V90M) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) glycerin (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) lauryl PEG-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA) glycyrrhiza glabra (UNII: 2788Z9758H) diethylhexyl syringylidenemalonate (UNII: 3V5U97P248) triethoxycaprylylsilane (UNII: LDC331P08E) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) aluminum hydroxide (UNII: 5QB0T2IUN0) stearic acid (UNII: 4ELV7Z65AP) butylene glycol (UNII: 3XUS85K0RA) caprylyl glycol (UNII: 00YIU5438U) dimethicone (UNII: 92RU3N3Y1O) ECTOINE (UNII: 7GXZ3858RY) phenoxyethanol (UNII: HIE492ZZ3T) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) disteardimonium hectorite (UNII: X687XDK09L) propylene carbonate (UNII: 8D08K3S51E) HYALURONATE SODIUM (UNII: YSE9PPT4TH) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 1,2-hexanediol (UNII: TR046Y3K1G) maltodextrin (UNII: 7CVR7L4A2D) tocopherol (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68745-2116-1 1 in 1 CARTON 06/01/2019 1 30 mL in 1 BOTTLE; 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 06/01/2019 Labeler - CHANEL PARFUMS BEAUTE (275137669) Establishment Name Address ID/FEI Business Operations CHANEL PARFUMS BEAUTE 277032517 MANUFACTURE(68745-2116) , LABEL(68745-2116)
