Miami Beach Spf 50 Kids C/s Sunscreen

Miami Beach Spf 50 Kids C/s Sunscreen
SPL v2
SPL
SPL Set ID 2bd8159f-c381-36b3-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-02-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30.66 mg) Homosalate (102.2 mg) Octisalate (51.1 mg) Octocrylene (28.11 mg)
Inactive Ingredients
Styrene/acrylamide Copolymer (mw 500000) Butyl Acrylate/c16-c20 Alkyl Methacrylate/methacrylic Acid/methyl Methacrylate Copolymer Potassium Cetyl Phosphate Dimethicone Crambe Maritima Leaf Medium-chain Triglycerides Ethylhexylglycerin Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Aloe Vera Leaf Sorbitol Propylene Glycol Edetate Disodium Aminomethylpropanol Pseudopterogorgia Elisabethae .alpha.-tocopherol Acetate Water Phenoxyethanol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-02-29

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 2.75%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 2.75%

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 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
  • Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F
Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Water (Aqua), Styrene/Acrylates Copolymer, Homosalate, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane, Sorbitol, Octocrylene, Dimethicone, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Phenoxyethanol, Potassium Cetyl Phosphate, Fragrance (Parfum), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Disodium EDTA, Tocopheryl Acetate, Butylphenyl Methylpropional, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Hexyl Cinnamal, Linalool, Geraniol, Alpha-Isomethyl Ionone, Caprylic/Capric Triglyceride, Benzyl Salicylate, Propylene Glycol, Hydroxycitronellal, Limonene, Crambe Maritima Extract, Pseudopterogorgia Elisabethae Plant Extract

Warnings

For external use only

Directions
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming and sweating
  • immediately after towel drying
  • at least every 2 hours
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly into face. Spray on hands then apply to face
  • do not apply in windy conditions
  • use in a well-ventilated area
  • 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 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
  • may stain fabrics
Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.75%

Question Or Comments?

Call 305.471.7989

Miami Beach Spf 50 C/s Sunscreen


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 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
  • Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F
Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Water (Aqua), Styrene/Acrylates Copolymer, Homosalate, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane, Sorbitol, Octocrylene, Dimethicone, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Phenoxyethanol, Potassium Cetyl Phosphate, Fragrance (Parfum), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Disodium EDTA, Tocopheryl Acetate, Butylphenyl Methylpropional, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Hexyl Cinnamal, Linalool, Geraniol, Alpha-Isomethyl Ionone, Caprylic/Capric Triglyceride, Benzyl Salicylate, Propylene Glycol, Hydroxycitronellal, Limonene, Crambe Maritima Extract, Pseudopterogorgia Elisabethae Plant Extract

Purpose

Sunscreen

Warnings

For external use only

Directions
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming and sweating
  • immediately after towel drying
  • at least every 2 hours
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly into face. Spray on hands then apply to face
  • do not apply in windy conditions
  • use in a well-ventilated area
  • 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 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
  • may stain fabrics
Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.75%

Question Or Comments? (Question or comments?)

Call 305.471.7989

Miami Beach Spf 50 C/s Sunscreen (Miami Beach SPF 50 C/S Sunscreen)


Advanced Ingredient Data


Raw Label Data

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