Neostrata Sheer Hydration Lotion
FDA Label NDC 58414-0020

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Neostrata Company Inc. for the product Neostrata Sheer Hydration (NDC 58414-0020). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients (w/w), purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients (W/W)

Avobenzone 3%, Octinoxate 7.5%, Octisalate 5%

Purpose

Sunscreen

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

Warnings

For external use only

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

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

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

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

Other Information

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

Inactive Ingredients

Aqua/Water/Eau, 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

Principal Display Panel - 50 Ml Bottle Carton

NEOSTRATA®

DEFEND

Sheer Hydration
Sunscreen Broad
Spectrum SPF 40

Lotion
DIN 02470535

50 mL/1.7 FL OZ

Principal Display Panel (50 mL Bottle Carton)

Principal Display Panel (50 mL Bottle Carton)

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