EXUVIANCE OPTILIGHT ALL-OVER DARK SPOT MINIMIZER WITH SUNSREEN BROAD SPECTRUM SPF 35- octinoxate, octisalate, and avobenzone cream

Exuviance OptiLight All-Over Dark Spot Minimizer by

Drug Labeling and Warnings

Exuviance OptiLight All-Over Dark Spot Minimizer by is a Otc medication manufactured, distributed, or labeled by NeoStrata Company Inc., Cosmetic Essence, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone 3%
Octinoxate 7.5%
Octisalate 5%

Purpose

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 rash occurs

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

Directions

• Apply liberally to face and neck daily, 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 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-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor

Inactive ingredients

Aqua/Water/Eau, Acetyl Glucosamine, Butyloctyl Salicylate, Dimethicone, C12-15 Alkyl Benzoate, Glycerin, Cyclopentasiloxane, Glyceryl Stearate, Butylene Glycol, Cyclohexasiloxane, Octyldodecyl Neopentanoate, Cetyl Alcohol, Cetearyl Alcohol, PEG-100 Stearate, Vitis Vinifera (Grape) Seed Extract, DL-Alpha Tocopheryl Acetate, Propylene Glycol, 4-Butylresorcinol, Ceteth-20, PEG-75 Stearate, Disodium EDTA, Steareth-20, Xanthan Gum, Ammonium Hydroxide, Caprylyl Glycol, Sodium Bisulfite, Carbomer, Tetrahydrodiferuloylmethane, Chlorphenesin, Phenoxyethanol.

Other information

• Store at 15°C-30°C (59°F-86°F)
• Protect this product from excessive heat and direct sun
• For easy product dispensing, store tube upright on its cap.

Questions or comments?

Call toll free 1-800-225-9411 (9am-5pm ET)

PRINCIPAL DISPLAY PANEL - 40 g Tube Carton

DERMATOLOGIST DEVELOPED

Exuviance®

OptiLight
All-Over Dark Spot Minimizer
with Sunscreen Broad Spectrum SPF 35

Minimizes appearance of dark spots
for an all-over even tone

Discourages new dark spots and
signs of photodamage

Antioxidants help ensure a bright,
youthful complexion

TARGETED

Net Wt 40 g / 1.4 oz

INGREDIENTS AND APPEARANCE

EXUVIANCE OPTILIGHT ALL-OVER DARK SPOT MINIMIZER   WITH SUNSREEN BROAD SPECTRUM SPF 35
octinoxate, octisalate, and avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58414-0016
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 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE 100 (UNII: RO266O364U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-100 STEARATE (UNII: YD01N1999R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
4-BUTYLRESORCINOL (UNII: 2IK4UQ3ZGA)
TETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03)
PEG-75 STEARATE (UNII: OT38R0N74H)
STEARETH-20 (UNII: L0Q8IK9E08)
CETETH-20 (UNII: I835H2IHHX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BISULFITE (UNII: TZX5469Z6I)
AMMONIA (UNII: 5138Q19F1X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58414-0016-1	1 in 1 CARTON	09/15/2018	07/31/2021
1		40 g in 1 TUBE; 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	09/15/2018	07/31/2021

Labeler - NeoStrata Company Inc. (605754829)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC		032565959	MANUFACTURE(58414-0016)