ocean potion suncare 30 continuous spray sunscreen scent of sunshine

ocean potion suncare 30 continuous spray sunscreen scent of sunshine
SPL v1
SPL
SPL Set ID 3e60bd44-1984-57c6-e063-6294a90a1f4e
Route
topical
Published
Effective Date 2024-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (100 mg) octocrylene (20 mg) octisalate (50 mg)
Inactive Ingredients
medium-chain triglycerides stearoxytrimethylsilane butyloctyl salicylate glycerin .alpha.-tocopherol, dl- acrylate/isobutyl methacrylate/n-tert-octylacrylamide copolymer (75000 mw) alcohol panthenol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-08-30

Purpose

Sunscreen

Description

Avobenzone 3.0% Homosalate 10.0% Octisalate 5.0% Octocrylene 2.0%


Medication Information

Warnings

For external use only

FLAMMABLE:

• do not use near heat, flame or while smoking

• avoid long term storage above 104°F (40°C)

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

Purpose

Sunscreen

Directions

• Spray liberally and spread evenly by hand 15 minutes before sun exposure

• Hold can 4-6 inches away from the skin to apply

• Do not spray directly into face. Spray into hands then apply to face

• Do not apply in windy conditions

• Use in a well-ventilated area

• reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

• 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 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

Other Information

• protect the product in this container from excessive heat and direct sun • may stain or damage some fabrics, materials or surfaces

Inactive Ingredients

alcohol denat., butyloctyl salicylate, acrylates/octylacrylamide copolymer, panthenol, tocopherol, fragrance,

stearoxytrimethylsilane, caprylic/capric triglyceride, glycerin

Description

Avobenzone 3.0% Homosalate 10.0% Octisalate 5.0% Octocrylene 2.0%

Labels

Do Not Use

• on damaged or broken skin.

Active Ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 2.0%

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 temperatures above 120° F.

Stop Use and Ask A Doctor If

• rash occurs.

Keep Out of Reach of Children.

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


Structured Label Content

Warnings

For external use only

FLAMMABLE:

• do not use near heat, flame or while smoking

• avoid long term storage above 104°F (40°C)

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

Purpose

Sunscreen

Directions

• Spray liberally and spread evenly by hand 15 minutes before sun exposure

• Hold can 4-6 inches away from the skin to apply

• Do not spray directly into face. Spray into hands then apply to face

• Do not apply in windy conditions

• Use in a well-ventilated area

• reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

• 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 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

Other Information (Other information)

• protect the product in this container from excessive heat and direct sun • may stain or damage some fabrics, materials or surfaces

Inactive Ingredients (Inactive ingredients)

alcohol denat., butyloctyl salicylate, acrylates/octylacrylamide copolymer, panthenol, tocopherol, fragrance,

stearoxytrimethylsilane, caprylic/capric triglyceride, glycerin

Labels

Do Not Use (Do not use)

• on damaged or broken skin.

Active Ingredients (Active ingredients)

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 2.0%

When Using This Product (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 temperatures above 120° F.

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


Advanced Ingredient Data


Raw Label Data

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