SPL v3
SPL
SPL Set ID e0983d07-efac-4738-acd7-2e86dffa552b
Route
TOPICAL
Published
Effective Date 2015-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30.33 mg) Homosalate (101.1 mg) Octisalate (50.55 mg) Octocrylene (27.8025 mg) Oxybenzone (20.22 mg)
Inactive Ingredients
(c10-c30)alkyl Methacrylate Ester Butyl Acrylate/c16-c20 Alkyl Methacrylate/methacrylic Acid/methyl Methacrylate Copolymer Aloe Vera Leaf Aminomethylpropanol N-butylphthalimide Isopropylphthalimide Edetate Disodium Phenoxyethanol Ethylhexylglycerin Potassium Cetyl Phosphate Propylene Glycol Water Pseudopterogorgia Elisabethae Caprylic/capric Acid Crambe Maritima Leaf Sorbitol Styrene/acrylamide Copolymer (mw 500000) Alpha-tocopherol Acetate

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-03-01

Description

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %,  Octocrylene 2.75 %, and Oxybenzone 2 %

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %,  Octocrylene 2.75 %, and Oxybenzone 2 %

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

Flammable: Do not use near heat, flame, or while smoking.

Do not use on damaged or broken skin

Section 60561-8

For external use only

Warnings

Directions
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • reapply: •after 80 minutes of swimming or 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 %, and Oxybenzone 2 %

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylane Copolymerm, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Butylphthalimide,Capylic/Capric Triglyceride, Crambe Maritima Extract, Disodium EDTA, Ethylhexylglycerin, Isopropylphthalimide, Phenoxyethanol, Potassium Cetyl Phosphate, Propylene Glycol, Pseudopterogorgia Elisabethae Plant Extract, Sorbitol, Styrene/ Acrylates Copolymer, Tocophenyl Acetate, Water

Questions Or Comments?

Call 305.471.7989

Principal Display Panel 148 Ml Can Label

OFFICIAL SUNCARE

MB

MIAMIBEACH

MB LIFEGUARDS

KIDS

CONTINUOUS SPRAY

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50

UVA/UVB Protection

Water Resistant (80 Minutes)

Dye-Free, Fragrance-Free

Hypoallergenic for Sensitive Skin

Made with Blend of Natural Marine Extracts

5 FL OZ (148mL)


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)

Flammable: Do not use near heat, flame, or while smoking.

Do not use on damaged or broken skin

Section 60561-8 (60561-8)

For external use only

Purpose

Sunscreen

Warnings

Directions
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • reapply: •after 80 minutes of swimming or 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 (Active ingredients)

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %,  Octocrylene 2.75 %, and Oxybenzone 2 %

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylane Copolymerm, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Butylphthalimide,Capylic/Capric Triglyceride, Crambe Maritima Extract, Disodium EDTA, Ethylhexylglycerin, Isopropylphthalimide, Phenoxyethanol, Potassium Cetyl Phosphate, Propylene Glycol, Pseudopterogorgia Elisabethae Plant Extract, Sorbitol, Styrene/ Acrylates Copolymer, Tocophenyl Acetate, Water

Questions Or Comments? (Questions or comments?)

Call 305.471.7989

Principal Display Panel 148 Ml Can Label (PRINCIPAL DISPLAY PANEL - 148 mL Can Label)

OFFICIAL SUNCARE

MB

MIAMIBEACH

MB LIFEGUARDS

KIDS

CONTINUOUS SPRAY

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50

UVA/UVB Protection

Water Resistant (80 Minutes)

Dye-Free, Fragrance-Free

Hypoallergenic for Sensitive Skin

Made with Blend of Natural Marine Extracts

5 FL OZ (148mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)