Myderm Hydrating Sunscreen Spray Broad Spectrum Spf 50 (is0002)

Myderm Hydrating Sunscreen Spray Broad Spectrum Spf 50 (is0002)
SPL v11
SPL
SPL Set ID 13271a1c-9d48-14cb-e063-6394a90ad607
Route
TOPICAL
Published
Effective Date 2024-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (15 g) Octocrylene (10 g) Avobenzone (3 g) Octisalate (5 g)
Inactive Ingredients
Glycerin Vitamin A Palmitate Diethylhexyl Syringylidenemalonate Caprylic/capric/lauric Triglyceride Aloe Vera Leaf Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (75000 Mw) Alcohol .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-01

Description

Active ingredient Avobenzone 3.0% Homosalate 15% Octisalate 5% Octocrylene 10%


Medication Information

Warnings and Precautions

Warnings

For External use only.

Indications and Usage

For external use only

Dosage and Administration

See Direction section for Dosage & Administration

Description

Active ingredient Avobenzone 3.0% Homosalate 15% Octisalate 5% Octocrylene 10%

Section 50565-1

Keep out of reach of children. If 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.

• Keep away from face to avoid breathing it.

• Do not puncture or incinerate, Contents under pressure

• Do not store at temperature above 120⁰F

Stop use and ask a doctor if rash occurs.

Section 51727-6

Inactive Ingredients

Acrylates/Octylacrylamide Copolymer

Alcohol Denat

Aloe Vera Oil Extract

Caprylic/Capric Triglyceride

Diethylhexyl Syringylidenemalonate

Glycerin

Tocopheryl Acetate

Retinyl Palmitate

Section 55105-1

Avobenzone 3.0% ……………………………………………………………………………… Sunscreen

Homosalate 15.0% ……………………………………………………………………………. Sunscreen

Octisalate 5.0% …………………………………………………………………………………. Sunscreen

Octocrylene 10.0% ……………………………………………………………………………. Sunscreen

Section 55106-9

Active ingredient

Avobenzone 3.0%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Myderm Hydrating Sunscreen Spray Broad Spectrum Spf 50


Structured Label Content

Indications and Usage (34067-9)

For external use only

Dosage and Administration (34068-7)

See Direction section for Dosage & Administration

Warnings and Precautions (34071-1)

Warnings

For External use only.

Section 50565-1 (50565-1)

Keep out of reach of children. If 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.

• Keep away from face to avoid breathing it.

• Do not puncture or incinerate, Contents under pressure

• Do not store at temperature above 120⁰F

Stop use and ask a doctor if rash occurs.

Section 51727-6 (51727-6)

Inactive Ingredients

Acrylates/Octylacrylamide Copolymer

Alcohol Denat

Aloe Vera Oil Extract

Caprylic/Capric Triglyceride

Diethylhexyl Syringylidenemalonate

Glycerin

Tocopheryl Acetate

Retinyl Palmitate

Section 55105-1 (55105-1)

Avobenzone 3.0% ……………………………………………………………………………… Sunscreen

Homosalate 15.0% ……………………………………………………………………………. Sunscreen

Octisalate 5.0% …………………………………………………………………………………. Sunscreen

Octocrylene 10.0% ……………………………………………………………………………. Sunscreen

Section 55106-9 (55106-9)

Active ingredient

Avobenzone 3.0%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Myderm Hydrating Sunscreen Spray Broad Spectrum Spf 50 (MyDerm Hydrating Sunscreen Spray Broad Spectrum SPF 50)


Advanced Ingredient Data


Raw Label Data

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