NEOSTRATA ENLIGHTEN SKIN BRIGHTENER WITH SUNSCREEN BROAD SPECTRUM SPF 35- octinoxate, octisalate, and avobenzone cream

NeoStrata Enlighten Skin Brightener by

Drug Labeling and Warnings

NeoStrata Enlighten Skin Brightener 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 (w/w)

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 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/Eau, 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 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?

1-800-628-9904

PRINCIPAL DISPLAY PANEL - 40 g Tube Carton

NEOSTRATA®

ENLIGHTEN

UNEVEN TONE AND
DARK SPOTS

Skin Brightener
with Sunscreen Broad
Spectrum SPF 35

NET WT

40 g / 1.4 OZ

INGREDIENTS AND APPEARANCE

NEOSTRATA ENLIGHTEN SKIN BRIGHTENER   WITH SUNSCREEN BROAD SPECTRUM SPF 35
octinoxate, octisalate, and avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58414-0019
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: 58414-0019-1	1 in 1 CARTON	12/01/2018
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	12/01/2018

Labeler - NeoStrata Company Inc. (605754829)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC		032565959	MANUFACTURE(58414-0019)