UV ESSENTIEL COMPLETE UV PROTECTION SUNSCREEN ANTIOXIDANT ANTI-POLLUTION BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, and octocrylene 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
Avobenzone 3%	Sunscreen
Homosalate 10%	Sunscreen
Octisalate 5%	Sunscreen
Octocrylene 5%	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 glycerin coco-caprylate/caprate caprylyl triacontanyl PVP alcohol pentylene glycol moringa oil/hydrogenated moringa oil esters jojoba esters behenyl alcohol squalane potassium cetyl phosphate yeast extract gardenia tahitensis flower extract zingiber officinale (ginger) root extract glycyrrhiza glabra (licorice) root extract polyglycerin-3 dipropylene glycol C14-22 alcohols pullulan dimethicone camellia oleifera seed oil phytosteryl canola glycerides fragrance butyrospermum parkii (shea) butter extract sorbitol chlorphenesin caprylyl glycol C12-20 alkyl glucoside xanthan gum sodium hyaluronate acacia decurrens flower wax helianthus annuus (sunflower) seed wax butylene glycol acacia senegal gum phytic acid trehalose 1,2-hexanediol sodium hydroxide tocopherol glucose sodium citrate ascorbyl palmitate sodium benzoate citric acid
BU000009A

Questions or comments?

Call 1-800-550-0005

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

UV
ESSENTIEL

COMPLETE UV PROTECTION
SUNSCREEN

ANTIOXIDANT - ANTI-POLLUTION
BROAD SPECTRUM SPF 50

CHANEL

30 ml
1 FL.OZ.

INGREDIENTS AND APPEARANCE

UV ESSENTIEL   COMPLETE UV PROTECTION SUNSCREEN ANTIOXIDANT ANTI-POLLUTION BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, and octocrylene emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68745-2157
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
glycerin (UNII: PDC6A3C0OX)
cocoyl caprylocaprate (UNII: 8D9H4QU99H)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
alcohol (UNII: 3K9958V90M)
pentylene glycol (UNII: 50C1307PZG)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
docosanol (UNII: 9G1OE216XY)
squalane (UNII: GW89575KF9)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
yeast, unspecified (UNII: 3NY3SM6B8U)
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)
ginger (UNII: C5529G5JPQ)
glycyrrhiza glabra (UNII: 2788Z9758H)
polyglycerin-3 (UNII: 4A0NCJ6RD6)
dipropylene glycol (UNII: E107L85C40)
C14-22 alcohols (UNII: B1K89384RJ)
pullulan (UNII: 8ZQ0AYU1TT)
dimethicone (UNII: 92RU3N3Y1O)
camellia oil (UNII: T1PE06G0VE)
shea butter (UNII: K49155WL9Y)
sorbitol (UNII: 506T60A25R)
chlorphenesin (UNII: I670DAL4SZ)
caprylyl glycol (UNII: 00YIU5438U)
C12-20 alkyl glucoside (UNII: K67N5Z1RUA)
xanthan gum (UNII: TTV12P4NEE)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
acacia decurrens flower wax (UNII: AU6XZE9IY9)
helianthus annuus seed wax (UNII: 42DG15CHXV)
butylene glycol (UNII: 3XUS85K0RA)
acacia (UNII: 5C5403N26O)
fytic acid (UNII: 7IGF0S7R8I)
trehalose (UNII: B8WCK70T7I)
1,2-hexanediol (UNII: TR046Y3K1G)
sodium hydroxide (UNII: 55X04QC32I)
tocopherol (UNII: R0ZB2556P8)
anhydrous dextrose (UNII: 5SL0G7R0OK)
sodium citrate, unspecified form (UNII: 1Q73Q2JULR)
ascorbyl palmitate (UNII: QN83US2B0N)
sodium benzoate (UNII: OJ245FE5EU)
anhydrous citric acid (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68745-2157-1	1 in 1 CARTON	05/01/2023
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 drug	M020	05/01/2023

Labeler - CHANEL PARFUMS BEAUTE (275137669)

Establishment
Name	Address	ID/FEI	Business Operations
CHANEL PARFUMS BEAUTE		277032517	MANUFACTURE(68745-2157) , LABEL(68745-2157)