Mango Bay Spf 50 Sport Sunscreen Spry

Mango Bay Spf 50 Sport Sunscreen Spry
SPL v9
SPL
SPL Set ID e25e4f76-8311-491b-e053-2a95a90a4fc8
Route
TOPICAL
Published
Effective Date 2022-06-25
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
Fragrance 13576 Vitamin A Palmitate Diethylhexyl Syringylidenemalonate Caprylic/capric/lauric Triglyceride Aloe Vera Leaf Behenyl Behenate Glycerin Tocopherol Stearoxytrimethylsilane Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (75000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-25

Description

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


Medication Information

Warnings and Precautions

For external use only.

Highly flammable. Do not apply or use product near heat, flame or while smoking.

Indications and Usage
  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection
  • 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.
Dosage and Administration

Directions

  • Apply liberally to cool, dry skin 15 minutes before sun exposure. Spray 4-6 inches from body, then rub in. Spray the sunscreen generously onto your hands first, and then rub it into the face.

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 a broad spectrum SPF of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10am - 2pm.
  • wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months: Ask a doctor.
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 50569-3

Stop use and ask a doctor is rash occurs.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

Behenyl Alcohol

BHT

Butyloctyl Salicylate

Caprylyl Methicone Dimethicone

Dimethyl Capramide

Disodium EDTA

Ethylhexyl Stearate

Ethylhexylglycerin

Fragrance

Glyceryl Stearate Hydrated Silica

PEG-100 Stearate

Phenoxyethanol

Polyester-8

Sodium Polyacrylate

Styrene/Acrylates Copolymer

Trideceth-6

Trimethylsiloxysilicate

VP/Hexadecene Copolymer

Water

Xanthan Gum

Section 51945-4

Section 53413-1

Questions or Comments?

1.833.679.3717 OR [email protected]

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%

Section 60561-8

Other information

Protect this product container from flames, excessive heat and direct sun. May stain some fabrics.


Structured Label Content

Indications and Usage (34067-9)
  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection
  • 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.
Dosage and Administration (34068-7)

Directions

  • Apply liberally to cool, dry skin 15 minutes before sun exposure. Spray 4-6 inches from body, then rub in. Spray the sunscreen generously onto your hands first, and then rub it into the face.

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 a broad spectrum SPF of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10am - 2pm.
  • wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months: Ask a doctor.
Warnings and Precautions (34071-1)

For external use only.

Highly flammable. Do not apply or use product near heat, flame or while smoking.

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 50569-3 (50569-3)

Stop use and ask a doctor is rash occurs.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)

Behenyl Alcohol

BHT

Butyloctyl Salicylate

Caprylyl Methicone Dimethicone

Dimethyl Capramide

Disodium EDTA

Ethylhexyl Stearate

Ethylhexylglycerin

Fragrance

Glyceryl Stearate Hydrated Silica

PEG-100 Stearate

Phenoxyethanol

Polyester-8

Sodium Polyacrylate

Styrene/Acrylates Copolymer

Trideceth-6

Trimethylsiloxysilicate

VP/Hexadecene Copolymer

Water

Xanthan Gum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments?

1.833.679.3717 OR [email protected]

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%

Section 60561-8 (60561-8)

Other information

Protect this product container from flames, excessive heat and direct sun. May stain some fabrics.


Advanced Ingredient Data


Raw Label Data

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