Derma E Sun Defense

Derma E Sun Defense
SPL v1
SPL
SPL Set ID 395b73a4-dae7-49da-9dab-ab622117c8c0
Route
TOPICAL
Published
Effective Date 2024-07-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (195 mg) Titanium Dioxide (26.4 mg)
Inactive Ingredients
Aluminum Oxide Ascorbic Acid Green Tea Leaf Medium-chain Triglycerides Caprylyl Caprylate/caprate Cetostearyl Alcohol Cetearyl Glucoside Cetearyl Olivate Coco-caprylate Coco-glucoside Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate Ethylhexylglycerin Glycerin Sunflower Oil Isostearic Acid Lecithin, Sunflower Microcrystalline Cellulose Panthenol Phenoxyethanol Fytic Acid Polyglyceryl-3 Pentaricinoleate Polyhydroxystearic Acid (2300 Mw) Water Betasizofiran Shea Butter Phytate Sodium Sorbitan Olivate Stearic Acid Stearyl/octyldodecyl Citrate Crosspolymer .alpha.-tocopherol Acetate Xanthan Gum Carboxymethylcellulose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-30

Description

Drug Facts


Medication Information

Description

Drug Facts

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
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 if rash occurs

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin

Section 55105-1
Active Ingredient Purpose
Zinc Oxide 19.5% } Sunscreen
Titanium Dioxide 2.64% } Sunscreen
Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • Children under 6 months of age: 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 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
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
Other Information
  • protect this product from excessive heat and direct sun
Inactive Ingredients

Aluminum Oxide, Ascorbic Acid, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Caprylyl Caprylate/Caprate, Cellulose Gum, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Coco-Caprylate, Coco-Glucoside, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Isostearic Acid, Lecithin, Microcrystalline Cellulose, Panthenol, Phenoxyethanol, Phytic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Purified Water, Sclerotium Gum, Butyrospermum Parkii (Shea) Butter, Sodium Phytate, Sorbitan Olivate, Stearic Acid, Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopheryl Acetate, Xanthan Gum.

*Certified Organic Ingredients

Questions Or Comments?

Call toll free 1-800-933-9344 or visit dermae.com

Principal Display Panel 113 G Tube Box

SUN CARE

New

&

Improved

FORMULA

DERMA • E

Sun Defense

Clear Zinc

Sunscreen

BROAD SPECTRUM

SPF 30

Mineral Clear Zinc Oxide

Vitamin E & Shea Butter

100% Unscented

spf

30

BODY

DERMATOLOGIST

RECOMMENDED

reef

safe

4 OZ / 113 g


Structured Label Content

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
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 if rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 55105-1 (55105-1)
Active Ingredient Purpose
Zinc Oxide 19.5% } Sunscreen
Titanium Dioxide 2.64% } Sunscreen
Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • Children under 6 months of age: 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 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
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
Other Information (Other information)
  • protect this product from excessive heat and direct sun
Inactive Ingredients

Aluminum Oxide, Ascorbic Acid, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Caprylyl Caprylate/Caprate, Cellulose Gum, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Coco-Caprylate, Coco-Glucoside, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Isostearic Acid, Lecithin, Microcrystalline Cellulose, Panthenol, Phenoxyethanol, Phytic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Purified Water, Sclerotium Gum, Butyrospermum Parkii (Shea) Butter, Sodium Phytate, Sorbitan Olivate, Stearic Acid, Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopheryl Acetate, Xanthan Gum.

*Certified Organic Ingredients

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-933-9344 or visit dermae.com

Principal Display Panel 113 G Tube Box (PRINCIPAL DISPLAY PANEL - 113 g Tube Box)

SUN CARE

New

&

Improved

FORMULA

DERMA • E

Sun Defense

Clear Zinc

Sunscreen

BROAD SPECTRUM

SPF 30

Mineral Clear Zinc Oxide

Vitamin E & Shea Butter

100% Unscented

spf

30

BODY

DERMATOLOGIST

RECOMMENDED

reef

safe

4 OZ / 113 g


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)