neostrata ®

neostrata ®
SPL v4
SPL
SPL Set ID e8cdf9f7-d968-42b3-bcb8-02dee7717fd8
Route
topical
Published
Effective Date 2023-08-30
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 cyclomethicone 5 glycerin alkyl (c12-15) benzoate dimethicone butylene glycol glyceryl monostearate octyldodecyl neopentanoate cetyl alcohol peg-100 stearate cetostearyl alcohol .alpha.-tocopherol acetate azadirachta indica leaf lecithin, soybean arctium lappa root vitis vinifera seed propylene glycol peg-75 stearate xanthan gum edetate disodium anhydrous ceteth-20 steareth-20 ammonia phenoxyethanol caprylyl glycol chlorphenesin sodium bisulfite carbomer homopolymer, unspecified type dimethicone crosspolymer (450000 mpa.s at 12% in cyclopentasiloxane)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-02-01
Purpose

Sunscreen

Description

Drug Facts

Medication Information

Warnings

For external use only

Uses
  • Helps prevent sunburn
  • Broad Spectrum SPF 40
  • 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
  • Children under 6 months: Ask a doctor
  • 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
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, Cyclopentasiloxane, Dimethicone, C12-15 Alkyl Benzoate, Glycerin, Butylene Glycol, Glyceryl Stearate, Octyldodecyl Neopentanoate, Cetyl Alcohol, PEG-100 Stearate, Cetearyl Alcohol, Vitis Vinifera (Grape) Seed Extract, Melia Azadirachta Leaf Extract, Lecithin, Arctium Lappa Root Extract, DL-Alpha Tocopheryl Acetate, Dimethicone Crosspolymer, Propylene Glycol, PEG-75 Stearate, Steareth-20, Xanthan Gum, Ceteth-20, Ammonium Hydroxide, Carbomer, Disodium EDTA, Caprylyl Glycol, Phenoxyethanol, Chlorphenesin, Sodium Bisulfite.

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 doctor ifrash occurs

Section 50567-7

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

Section 50570-1

Do not useon damaged or broken skin.

Active Ingredients (w/w)

Avobenzone 3%, Octinoxate 7.5%, Octisalate 5%

Principal Display Panel 50 Ml Bottle Carton

NEOSTRATA ®

DEFEND

Sheer Hydration

Sunscreen Broad

Spectrum SPF 40

Lotion

DIN 02482010

50 mL/1.7 FL OZ

Structured Label Content

Warnings

For external use only

Uses
  • Helps prevent sunburn
  • Broad Spectrum SPF 40
  • 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
  • Children under 6 months: Ask a doctor
  • 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
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, Cyclopentasiloxane, Dimethicone, C12-15 Alkyl Benzoate, Glycerin, Butylene Glycol, Glyceryl Stearate, Octyldodecyl Neopentanoate, Cetyl Alcohol, PEG-100 Stearate, Cetearyl Alcohol, Vitis Vinifera (Grape) Seed Extract, Melia Azadirachta Leaf Extract, Lecithin, Arctium Lappa Root Extract, DL-Alpha Tocopheryl Acetate, Dimethicone Crosspolymer, Propylene Glycol, PEG-75 Stearate, Steareth-20, Xanthan Gum, Ceteth-20, Ammonium Hydroxide, Carbomer, Disodium EDTA, Caprylyl Glycol, Phenoxyethanol, Chlorphenesin, Sodium Bisulfite.

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 doctor ifrash 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 useon damaged or broken skin.

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

Avobenzone 3%, Octinoxate 7.5%, Octisalate 5%

Principal Display Panel 50 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton)

NEOSTRATA ®

DEFEND

Sheer Hydration

Sunscreen Broad

Spectrum SPF 40

Lotion

DIN 02482010

50 mL/1.7 FL OZ

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:19.304819 · Updated: 2026-03-14T23:06:57.309434