EXUVIANCE OPTILIGHT ALL-OVER DARK SPOT MINIMIZER  SPF 25- octinoxate, octisalate, and avobenzone cream 
NeoStrata Company Inc.

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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Exuviance® Optilight All-Over Dark Spot Minimizer
SPF 25

Drug Facts

Active ingredients

Ethylhexyl Methoxycinnamate (Octinoxate) (7.5%)
Ethylhexyl Salicylate (Octisalate) (5%)
Butyl Methoxydibenzoylmethane (Avobenzone) (3%)

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

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 25

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

Helps prevent new dark spots and
signs of photodamage

Antioxidants help ensure a bright,
youthful complexion

TARGETED

Net Wt 40 g / 1.4 oz

Principal Display Panel - 40 g Tube Carton
EXUVIANCE OPTILIGHT ALL-OVER DARK SPOT MINIMIZER   SPF 25
octinoxate, octisalate, and avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58414-2099
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58414-2099-11 in 1 CARTON02/01/201506/15/2021
140 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/201506/15/2021
Labeler - NeoStrata Company Inc. (605754829)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Essence, LLC825646862MANUFACTURE(58414-2099)

Revised: 3/2018
Document Id: 435874c3-3437-4db9-96a0-3a68540a35f5
Set id: ef2eb57c-6707-4684-b4f3-b9de41e3cfd5
Version: 2
Effective Time: 20180314
 
NeoStrata Company Inc.