Neostrata ®

Neostrata ®
SPL v7
SPL
SPL Set ID 8e4b9c08-b906-4c5f-a243-55838ae28b90
Route
TOPICAL
Published
Effective Date 2023-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octinoxate (75 mg) Octisalate (50 mg)
Inactive Ingredients
Water N-acetylglucosamine Butyloctyl Salicylate Cyclomethicone 5 Glyceryl Monostearate Butylene Glycol Shea Butter Peg-100 Stearate Dimethicone Cetyl Alcohol Nylon-12 Tricontanyl Povidone Retinol .alpha.-tocopherol Acetate Palmitoyl Tripeptide-1 Palmitoyl Tetrapeptide-7 Punica Granatum Root Bark Coffea Arabica Fruit Rosa X Damascena Flower Oil Arginine Glycerin Propylene Glycol Triethyl Citrate Cyclomethicone 6 Caprylyl Glycol Citric Acid Monohydrate Edetate Disodium Anhydrous Butylated Hydroxytoluene Peg-75 Stearate Ceteth-20 Steareth-20 Dimethiconol (100000 Cst) Polysorbate 20 Xanthan Gum Ammonium Acryloyldimethyltaurate/vp Copolymer Methyl Dihydrojasmonate (synthetic) Carbomer Homopolymer, Unspecified Type Ethylene Brassylate Chlorphenesin Phenoxyethanol Fd&c Yellow No. 5 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-07-18
Description

Drug Facts

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses
  • Helps prevent sunburn
  • Broad Spectrum SPF 30
  • 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 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.

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, Cyclopentasiloxane, Glyceryl Stearate, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, PEG-100 Stearate, Dimethicone, Cetyl Alcohol, Nylon-12, Triacontanyl PVP, Retinol, Citric Acid, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Coffea Arabica (Coffee) Fruit Extract, DL-Alpha Tocopheryl Acetate, Rosa Damascena Flower Oil, Punica Granatum Extract, Arginine, Glycerin, Propylene Glycol, Cyclohexasiloxane, Caprylyl Glycol, Dimethiconol, Disodium EDTA, BHT, Xanthan Gum, PEG-75 Stearate, Ceteth-20, Steareth-20, Polysorbate 20, Triethyl Citrate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Methyldihydrojasmonate, Carbomer, Ethylene Brassylate, Phenoxyethanol, Chlorphenesin, Yellow 5 (CI 19140), Red 33 (CI 17200).

Active Ingredients (w/w)

Avobenzone 3%,

Octinoxate 7.5%,

Octisalate 5%

Principal Display Panel 50 G Tube Carton

NEOSTRATA ®

SKIN ACTIVE

REPAIR

Matrix Support

with Sunscreen Broad

Spectrum SPF 30

Cream

DIN 02470527

NET WT

50 g/1.7 OZ

Structured Label Content

Uses
  • Helps prevent sunburn
  • Broad Spectrum SPF 30
  • 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 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.

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, Cyclopentasiloxane, Glyceryl Stearate, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, PEG-100 Stearate, Dimethicone, Cetyl Alcohol, Nylon-12, Triacontanyl PVP, Retinol, Citric Acid, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Coffea Arabica (Coffee) Fruit Extract, DL-Alpha Tocopheryl Acetate, Rosa Damascena Flower Oil, Punica Granatum Extract, Arginine, Glycerin, Propylene Glycol, Cyclohexasiloxane, Caprylyl Glycol, Dimethiconol, Disodium EDTA, BHT, Xanthan Gum, PEG-75 Stearate, Ceteth-20, Steareth-20, Polysorbate 20, Triethyl Citrate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Methyldihydrojasmonate, Carbomer, Ethylene Brassylate, Phenoxyethanol, Chlorphenesin, Yellow 5 (CI 19140), Red 33 (CI 17200).

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

Avobenzone 3%,

Octinoxate 7.5%,

Octisalate 5%

Principal Display Panel 50 G Tube Carton (PRINCIPAL DISPLAY PANEL - 50 g Tube Carton)

NEOSTRATA ®

SKIN ACTIVE

REPAIR

Matrix Support

with Sunscreen Broad

Spectrum SPF 30

Cream

DIN 02470527

NET WT

50 g/1.7 OZ

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-03-06T01:27:44.054398 · Updated: 2026-03-14T23:14:02.652954