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
Purpose

Sunscreen

Description

Drug Facts

Medication Information

Warnings

For external use only

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
Purpose

Sunscreen

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
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.

Description

Drug Facts

Questions?

1-800-628-9904

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

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

Warnings

For external use only

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
Purpose

Sunscreen

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
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.

Questions?

1-800-628-9904

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

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