Miami Beach Sea Sunscreen Lotion 30 Broad Spectrum Spf 30

Miami Beach Sea Sunscreen Lotion 30 Broad Spectrum Spf 30
SPL v2
SPL
SPL Set ID 6866cb26-9ec5-1b58-e053-2a91aa0a7b8d
Route
TOPICAL
Published
Effective Date 2018-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (99.6 mg) Avobenzone (29.88 mg) Octisalate (49.8 mg) Homosalate
Inactive Ingredients
Trolamine Ethylhexyl Palmitate Oleth-3 Dulse Propylene Glycol Sorbitol Edetic Acid Carbomer 1342 Benzyl Alcohol Medium-chain Triglycerides Fucus Serratus Polyamide-8 (4500 Mw) Chlorphenesin Diethylhexyl Syringylidenemalonate Macrocystis Pyrifera Sodium Ascorbyl Phosphate Tocopherol Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-03-27

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 10%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 10%

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 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

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

Section 50569-3

Stop use and ask a doctor if rash occurs

Section 50570-1

Do not use on damaged or broken skin

Warnings

For external use only

Directions

• apply liberally 15 minutes before sun exposure

• reapply: • after 80 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 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 • children under 6 months: Ask a doctor

Other Information

• protect this product from excessive heat and direct sun. • avoid contact with clothing to avoid staining.

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Caprylic/Capric Triglyceride, Chlorphenesin, Diethylhexyl Syringylidene-malonate, Disodium EDTA, Ethylhexyl Palmitate, Fragrance, Fucus Serratus (Seaweed) Extract, Macrocystis Pyrifera (Kelp) Extract, Oleth-3, Palmaria Palmata (Algae) Extract, Polyamide-8, Propylene Glycol, Sodium Ascorbyl Phosphate, Sorbitol, Tocopherol, Triethanolamine, Water

Questions Or Comments?

Call 305.592.8565

Miami Beach Sea Sunscreen Lotion Broad Spectrum Spf 30


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 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 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

Stop use and ask a doctor if rash occurs

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Purpose

Sunscreen

Warnings

For external use only

Directions

• apply liberally 15 minutes before sun exposure

• reapply: • after 80 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 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 • children under 6 months: Ask a doctor

Other Information (Other information)

• protect this product from excessive heat and direct sun. • avoid contact with clothing to avoid staining.

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Inactive Ingredients (Inactive ingredients)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Caprylic/Capric Triglyceride, Chlorphenesin, Diethylhexyl Syringylidene-malonate, Disodium EDTA, Ethylhexyl Palmitate, Fragrance, Fucus Serratus (Seaweed) Extract, Macrocystis Pyrifera (Kelp) Extract, Oleth-3, Palmaria Palmata (Algae) Extract, Polyamide-8, Propylene Glycol, Sodium Ascorbyl Phosphate, Sorbitol, Tocopherol, Triethanolamine, Water

Questions Or Comments? (Questions or comments?)

Call 305.592.8565

Miami Beach Sea Sunscreen Lotion Broad Spectrum Spf 30 (Miami Beach Sea Sunscreen Lotion Broad Spectrum SPF 30)


Advanced Ingredient Data


Raw Label Data

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