Solvaderm Dermaxsol Dermal Defense Moisturizer Spf-30

Solvaderm Dermaxsol Dermal Defense Moisturizer Spf-30
SPL v1
SPL
SPL Set ID 0f9a507a-1b72-45f8-a8a8-b7a92a85607f
Route
TOPICAL
Published
Effective Date 2024-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (100 mg) Zinc Cation (70 mg)
Inactive Ingredients
Aloe Vera Leaf Aluminum Starch Octenylsuccinate Water Yellow Wax Calendula Officinalis Flower Green Tea Leaf Cetostearyl Alcohol Cyclomethicone 5 Diisopropyl Adipate Dimethicone Ethylhexylglycerin Glycerin Glyceryl Laurate Glyceryl Monostearate Hyaluronic Acid C13-14 Isoparaffin Laureth-7 Peg-100 Stearate Phenoxyethanol Sorbitan Monostearate Stearyl Alcohol .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-04

Description

Octocrylene 10.0%  Zinc Oxide 7.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octocrylene 10.0%  Zinc Oxide 7.0%

Uses:

Helps prevent sunburn.

Warnings:

For external use only.

Drug Facts

Do Not Use

on damaged or broken skin.

Directions:

Apply to all skin exposed to the sun.

*Apply liberally and evenly 15 minutes before sun exposure.

*Reapply at least every 2 hours.

*Use a water-resistant sunscreen if swimming or sweating.

*If pregnant or breast-feeding, ask a health care professional before use.

*For children under 6 months of age: Ask a doctor.

Package Labeling:

Other Information:

Protect the product in this container from excessive heat and direct sun.

Active Ingredients:

Octocrylene 10.0% 

Zinc Oxide 7.0%

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aluminum Starch Octenyl succinate, Aqua (Deionized Water), Beeswax, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Chamomilla Matricaria Extract, Cetearyl Alcohol, Cyclopentasiloxane, Diisopropyl Adipate, Dimethicone, Dimethiconol, Ethylhexylglycerin, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Hyaluronic Acid, C13-14 Isoparaffin, Laureth-7, Parfum (Fragrance)., PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Sorbitan Stearate, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E).

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


Structured Label Content

Uses: (USES:)

Helps prevent sunburn.

Purpose (PURPOSE)

Sunscreen

Warnings: (WARNINGS:)

For external use only.

Drug Facts (DRUG FACTS)

Do Not Use (Do not use)

on damaged or broken skin.

Directions: (DIRECTIONS:)

Apply to all skin exposed to the sun.

*Apply liberally and evenly 15 minutes before sun exposure.

*Reapply at least every 2 hours.

*Use a water-resistant sunscreen if swimming or sweating.

*If pregnant or breast-feeding, ask a health care professional before use.

*For children under 6 months of age: Ask a doctor.

Package Labeling:

Other Information: (OTHER INFORMATION:)

Protect the product in this container from excessive heat and direct sun.

Active Ingredients: (ACTIVE INGREDIENTS:)

Octocrylene 10.0% 

Zinc Oxide 7.0%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aluminum Starch Octenyl succinate, Aqua (Deionized Water), Beeswax, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Chamomilla Matricaria Extract, Cetearyl Alcohol, Cyclopentasiloxane, Diisopropyl Adipate, Dimethicone, Dimethiconol, Ethylhexylglycerin, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Hyaluronic Acid, C13-14 Isoparaffin, Laureth-7, Parfum (Fragrance)., PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Sorbitan Stearate, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E).

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs.

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.


Advanced Ingredient Data


Raw Label Data

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