UV ESSENTIEL DAILY DEFENSE SUNSCREEN ANTI-POLLUTION BROAD SPECTRUM SPF 50

Drug Labeling and Warnings

Drug Details [pdf]

UV ESSENTIEL  DAILY DEFENSE SUNSCREEN ANTI-POLLUTION BROAD SPECTRUM SPF 50- octinoxate, titanium dioxide, and zinc oxide emulsion 
CHANEL PARFUMS BEAUTE

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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UV ESSENTIEL
DAILY DEFENSE SUNSCREEN ANTI-POLLUTION BROAD SPECTRUM SPF 50

Drug Facts

Active ingredients	Purpose
Octinoxate 7.5%	Sunscreen
Titanium dioxide 5.4%	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 hydrogenated polyisobutene alcohol caprylyl methicone glycerin polymethylsilsesquioxane lauryl PEG-9 polydimethylsiloxyethyl dimethicone triethoxycaprylylsilane polymethyl methacrylate gardenia tahitensis flower extract glycyrrhiza glabra (licorice) root extract diethylhexyl syringylidenemalonate dipropylene glycol stearic acid aluminum hydroxide butylene glycol fragrance caprylyl glycol ectoin phenoxyethanol alumina caprylic/capric triglyceride disteardimonium hectorite propylene carbonate sodium hyaluronate pentylene glycol tocopheryl acetate silica BHT 3-aminopropane sulfonic acid calcium hydroxymethionine polysorbate 20 hydroxyethylcellulose tocopherol

Questions or comments?

Call 1-800-550-0005 M – F 10am –8pm, S – S 12pm – 6pm EST.

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

UV ESSENTIEL

MULTI-PROTECTION
DAILY DEFENSE SUNSCREEN

ANTI-POLLUTION
BROAD SPECTRUM SPF 50

CHANEL

30 ml
1 FL.OZ.

UV ESSENTIEL   DAILY DEFENSE SUNSCREEN ANTI-POLLUTION BROAD SPECTRUM SPF 50
octinoxate, titanium dioxide, and zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68745-2066
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	54 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)
alcohol (UNII: 3K9958V90M)
caprylyl trisiloxane (UNII: Q95M2P1KJL)
glycerin (UNII: PDC6A3C0OX)
lauryl PEG-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
triethoxycaprylylsilane (UNII: LDC331P08E)
gardenia taitensis flower (UNII: T0OCU8201Y)
glycyrrhiza glabra (UNII: 2788Z9758H)
diethylhexyl syringylidenemalonate (UNII: 3V5U97P248)
dipropylene glycol (UNII: E107L85C40)
stearic acid (UNII: 4ELV7Z65AP)
aluminum hydroxide (UNII: 5QB0T2IUN0)
butylene glycol (UNII: 3XUS85K0RA)
caprylyl glycol (UNII: 00YIU5438U)
ectoine (UNII: 7GXZ3858RY)
phenoxyethanol (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
disteardimonium hectorite (UNII: X687XDK09L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
propylene carbonate (UNII: 8D08K3S51E)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
pentylene glycol (UNII: 50C1307PZG)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TRAMIPROSATE (UNII: 5K8EAX0G53)
DESMENINOL CALCIUM (UNII: 1VK0YS654L)
polysorbate 20 (UNII: 7T1F30V5YH)
tocopherol (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68745-2066-1	1 in 1 CARTON	02/18/2016	07/31/2019
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68745-2066-2	1 mL in 1 PACKET; Type 0: Not a Combination Product	02/18/2016	07/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/18/2016	07/31/2019

Labeler - CHANEL PARFUMS BEAUTE (275137669)

Establishment
Name	Address	ID/FEI	Business Operations
CHANEL PARFUMS BEAUTE		277032517	MANUFACTURE(68745-2066) , LABEL(68745-2066)

Revised: 8/2019

Document Id: f4efcd57-7d64-4c69-9aff-90f961f69727

34390-5

Set id: 63a80f9e-99ac-404a-ba91-e21243a5999d

Version: 3

Effective Time: 20190805