Derma Soleil Dry Sport Spf 30

Derma Soleil Dry Sport Spf 30
SPL v1
SPL
SPL Set ID 9f1ff1c9-6d03-441c-e053-2995a90a5d88
Route
TOPICAL
Published
Effective Date 2020-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxybenzone (5 g) Octinoxate (7.5 g) Octisalate (4 g) Octocrylene
Inactive Ingredients
Chamomile Flower Oil Glyceryl Caprylate Levulinic Acid Sodium Anisate Carbomer Interpolymer Type A (55000 Cps) Calendula Officinalis Flower Hydrolyzed Wheat Protein (enzymatic; 3000 Mw) Vitamin A Palmitate Ascorbic Acid Titanium Dioxide Hypromelloses Aloe Vera Leaf Jojoba Oil .alpha.-tocopherol Acetate Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Avocado Oil Carboxypolymethylene Glycerin Evening Primrose Oil Grape Seed Oil Alkyl (c12-15) Benzoate Water Edetic Acid Aminomethylpropanol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-02-21

Description

Octocrylene 4% Octyl Methoxycinnamate 7.5%, Octyl Salicylate 4%, Oxybenzone 5%


Medication Information

Warnings and Precautions

For external use only.

Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs.

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

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Indications and Usage

• Apply liberally 15 minutes before sun exposure • Reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • 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 value 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-sleeved shirts, pants, hats, and sunglasses • children under 6 months of age: ask a doctor

Description

Octocrylene 4% Octyl Methoxycinnamate 7.5%, Octyl Salicylate 4%, Oxybenzone 5%

Section 50567-7

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 51727-6

Aloe Vera Gel, C12-15 Alkyl Benzoate, Aqua and Glycerin and Sodium Levulinate and Sodium Anisate, Fragrance, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Aminomethyl Propanol, Carbomer, Titanium Dioxide, Hydroxypropyl Methylcellulose, Tetrasodium EDTA, Evening Primrose Oil, Avocado Oil, Jojoba Oil, Grape Seed Oil, Blue Chamomile Oil, Calendula Oil, Hydrolyzed Wheat Protein, Retinyl Palmitate, Ascorbic Acid, Tocopherol Acetate.

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Octocrylene 4%

Octyl Methoxycinnamate 7.5%,

Octyl Salicylate 4%,

Oxybenzone 5%


Structured Label Content

Indications and Usage (34067-9)

• Apply liberally 15 minutes before sun exposure • Reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • 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 value 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-sleeved shirts, pants, hats, and sunglasses • children under 6 months of age: ask a doctor

Warnings and Precautions (34071-1)

For external use only.

Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs.

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

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Section 50567-7 (50567-7)

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 51727-6 (51727-6)

Aloe Vera Gel, C12-15 Alkyl Benzoate, Aqua and Glycerin and Sodium Levulinate and Sodium Anisate, Fragrance, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Aminomethyl Propanol, Carbomer, Titanium Dioxide, Hydroxypropyl Methylcellulose, Tetrasodium EDTA, Evening Primrose Oil, Avocado Oil, Jojoba Oil, Grape Seed Oil, Blue Chamomile Oil, Calendula Oil, Hydrolyzed Wheat Protein, Retinyl Palmitate, Ascorbic Acid, Tocopherol Acetate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Octocrylene 4%

Octyl Methoxycinnamate 7.5%,

Octyl Salicylate 4%,

Oxybenzone 5%


Advanced Ingredient Data


Raw Label Data

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