Neostrata ®

Neostrata ®
SPL v4
SPL
SPL Set ID ed495f18-2f8e-4991-b797-82e9f6fc7acb
Route
TOPICAL
Published
Effective Date 2023-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Octisalate (50 mg) Avobenzone (30 mg)
Inactive Ingredients
Water N-acetylglucosamine Butyloctyl Salicylate Dimethicone Alkyl (c12-15) Benzoate Glycerin Cyclomethicone 5 Glyceryl Monostearate Butylene Glycol Cyclomethicone 6 Octyldodecyl Neopentanoate Cetyl Alcohol Peg-100 Stearate Cetostearyl Alcohol Vitis Vinifera Seed .alpha.-tocopherol Acetate Propylene Glycol Edetate Disodium Anhydrous 4-butylresorcinol Tetrahydrodiferuloylmethane Peg-75 Stearate Steareth-20 Ceteth-20 Xanthan Gum Sodium Bisulfite Ammonia Caprylyl Glycol Phenoxyethanol Chlorphenesin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-12-01
Description

Drug Facts

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctorif rash occurs

Section 50567-7

When using this productkeep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Warnings

For external use only

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
Questions?

1-800-628-9904

Other Information
  • Store at 15°C-30°C (59°F-86°F)
  • Protect this product from excessive heat and direct sun
Inactive Ingredients

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 Acetate, Vitis Vinifera (Grape) Seed Extract, Tetrahydrodiferuloylmethane, 4-Butyl-resorcinol, Ceteth-20, PEG-75 Stearate, Propylene Glycol, Disodium EDTA, Steareth-20, Xanthan Gum, Ammonium Hydroxide, Sodium Bisulfite, Carbomer, Caprylyl Glycol, Phenoxyethanol, Chlorphenesin.

Active Ingredients (w/w)

Avobenzone 3%, Octinoxate 7.5%, Octisalate 5%

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

Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctorif rash occurs

Section 50567-7 (50567-7)

When using this productkeep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Purpose

Sunscreen

Warnings

For external use only

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
Questions?

1-800-628-9904

Other Information (Other information)
  • Store at 15°C-30°C (59°F-86°F)
  • Protect this product from excessive heat and direct sun
Inactive Ingredients (Inactive ingredients)

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 Acetate, Vitis Vinifera (Grape) Seed Extract, Tetrahydrodiferuloylmethane, 4-Butyl-resorcinol, Ceteth-20, PEG-75 Stearate, Propylene Glycol, Disodium EDTA, Steareth-20, Xanthan Gum, Ammonium Hydroxide, Sodium Bisulfite, Carbomer, Caprylyl Glycol, Phenoxyethanol, Chlorphenesin.

Active Ingredients (w/w) (Active ingredients (w/w))

Avobenzone 3%, Octinoxate 7.5%, Octisalate 5%

Principal Display Panel 40 G Tube Carton (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:19.314666 · Updated: 2026-03-14T23:06:57.309434