Mederma® Drug Facts

Mederma® Drug Facts
SPL v3
SPL
SPL Set ID f9be5adb-dce3-4b17-939f-d80d486f2cb0
Route
TOPICAL
Published
Effective Date 2023-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octocrylene (100 mg) Oxybenzone (60 mg)
Inactive Ingredients
Water Alkyl (c12-15) Benzoate Dicaprylyl Carbonate Alcohol Medium-chain Triglycerides Hydrogenated Soybean Lecithin Panthenol Glycerin Pentylene Glycol Phenoxyethanol Shea Butter Onion Ammonium Acryloyldimethyltaurate/vp Copolymer Squalane Methylparaben Xanthan Gum Propylparaben Edetate Disodium Anhydrous Hyaluronate Sodium Ethylparaben Ceramide Np Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-08-20
Description

Avobenzone 3% Octocrylene 10% Oxybenzone 6%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Octocrylene 10% Oxybenzone 6%

Uses
  • •
    Helps prevent sunburn
Warnings
  • •
    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
  • •
    For external use only
Directions
  • •
    For sunscreen use: Apply liberally 15 minutes before sun exposure
  • •
    Reapply at least every 2 hours
  • •
    Children under 6 months: Ask a doctor
  • •
    Use a water-resistant sunscreen if swimming or sweating
Do Not Use On
  • •
    Damaged or broken skin
Other Information
  • •
    Store at room temperature
  • •
    Protect this product from excessive heat and direct sun
Active Ingredients

Avobenzone 3%

Octocrylene 10%

Oxybenzone 6%

Inactive Ingredients
  • •
    Water, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Alcohol, Caprylic/Capric Triglyceride, Hydrogenated Phosphatidylcholine, Panthenol, Glycerin, Pentylene Glycol, Phenoxyethanol, Butyrospermum Parkii (Shea) Butter, Allium Cepa (Onion) Bulb Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Fragrance, Squalane, Methylparaben, Xanthan Gum, Propylparaben, Disodium EDTA, Sodium Hyaluronate, Ethylparaben, Ceramide NP, Tocopherol.
Questions Or Comments
  • •
    For more information call 1-833-426-6733 or visit www.mederma.com
When Using This Product
  • •
    Keep out of eyes
  • •
    Rinse with water to remove
Stop Use and Ask A Doctor
  • •
    If rash occurs
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Package Label.principal Display Panel

MEDERMA®



Scar Cream + SPF 30  



Clinically shown to visibly reduce the appearance of scars while protecting from sun damage



No. 1 Doctor & Pharmacist recommended scar brand



Sunscreen



1 x CREAM TUBE



NET WT. 0.7 0z (20g)



Unique Triple-Action Formula penetrates into the skin

Structured Label Content

Uses
  • •
    Helps prevent sunburn
Purpose

Sunscreen

Warnings
  • •
    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
  • •
    For external use only
Directions
  • •
    For sunscreen use: Apply liberally 15 minutes before sun exposure
  • •
    Reapply at least every 2 hours
  • •
    Children under 6 months: Ask a doctor
  • •
    Use a water-resistant sunscreen if swimming or sweating
Do Not Use On (Do not use on)
  • •
    Damaged or broken skin
Other Information
  • •
    Store at room temperature
  • •
    Protect this product from excessive heat and direct sun
Active Ingredients

Avobenzone 3%

Octocrylene 10%

Oxybenzone 6%

Inactive Ingredients
  • •
    Water, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Alcohol, Caprylic/Capric Triglyceride, Hydrogenated Phosphatidylcholine, Panthenol, Glycerin, Pentylene Glycol, Phenoxyethanol, Butyrospermum Parkii (Shea) Butter, Allium Cepa (Onion) Bulb Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Fragrance, Squalane, Methylparaben, Xanthan Gum, Propylparaben, Disodium EDTA, Sodium Hyaluronate, Ethylparaben, Ceramide NP, Tocopherol.
Questions Or Comments (Questions or Comments)
  • •
    For more information call 1-833-426-6733 or visit www.mederma.com
When Using This Product (When using this product)
  • •
    Keep out of eyes
  • •
    Rinse with water to remove
Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • •
    If rash occurs
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

MEDERMA®



Scar Cream + SPF 30  



Clinically shown to visibly reduce the appearance of scars while protecting from sun damage



No. 1 Doctor & Pharmacist recommended scar brand



Sunscreen



1 x CREAM TUBE



NET WT. 0.7 0z (20g)



Unique Triple-Action Formula penetrates into the skin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:25.813462 · Updated: 2026-03-14T23:07:12.329439