UV ESSENTIEL COMPLETE PROTECTION ANTIOXIDANT ANTI-POLLUTION SUNSCREEN BROAD SPECTRUM SPF 50- octinoxate, titanium dioxide, and zinc oxide emulsion

UV ESSENTIEL by

Drug Labeling and Warnings

UV ESSENTIEL by is a Otc medication manufactured, distributed, or labeled by CHANEL PARFUMS BEAUTE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Octinoxate 7.5%	Sunscreen
Titanium dioxide 3.8%	Sunscreen
Zinc oxide 17.1%	Sunscreen

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

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 skin rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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
• 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

Other information

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

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
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Questions or comments?

Call 1-800-550-0005 M – F 9am –9pm EST, S – S 10am – 6pm EST.

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

UV
ESSENTIEL

COMPLETE PROTECTION

ANTIOXIDANT
ANTI-POLLUTION SUNSCREEN
BROAD SPECTRUM SPF 50

CHANEL

30 ml
1 FL.OZ.

INGREDIENTS AND APPEARANCE

UV ESSENTIEL   COMPLETE PROTECTION ANTIOXIDANT ANTI-POLLUTION SUNSCREEN BROAD SPECTRUM SPF 50
octinoxate, titanium dioxide, and zinc oxide emulsion

Product 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)