NEOSTRATA ENLIGHTEN SKIN BRIGHTENER  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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NeoStrata® Enlighten Skin Brightener
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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply sunscreen 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, Tocopheryl (Vitamin E) Acetate, Vitis Vinifera (Grape) Seed Extract, Tetrahydrodiferuloylmethane, 4-Butylresorcinol, Ceteth-20, PEG-75 Stearate, Propylene Glycol, Disodium EDTA, Steareth-20, Xanthan Gum, Ammonium Hydroxide, Sodium Bisulfite, Carbomer, 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

Questions or comments?

Call toll free 1-800-628-9904 (9am-5pm ET)

PRINCIPAL DISPLAY PANEL - 40 g Tube Carton

NeoStrata®
ENLIGHTEN

Promotes bright
even skin tone

Skin
Brightener

with Sunscreen
Broad Spectrum SPF 25

NeoGlucosamine®
B-Resorcinol
SabiWhite®
Chardonnay Grape
Seed Extract
Vitamin E

Net Wt 40 g / 1.4 oz

PRINCIPAL DISPLAY PANEL - 40 g Tube Carton
NEOSTRATA ENLIGHTEN SKIN BRIGHTENER   SPF 25
octinoxate, octisalate, and avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58414-0011
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:58414-0011-11 in 1 CARTON10/01/201507/31/2021
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 FINALpart35210/01/201507/31/2021
Labeler - NeoStrata Company Inc. (605754829)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Essence, LLC825646862MANUFACTURE(58414-0011)

Revised: 6/2018
 
NeoStrata Company Inc.