e0983d07-efac-4738-acd7-2e86dffa552b

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

Purpose

Sunscreen

Description

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


Medication Information

Warnings

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
  • 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.

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

Description

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

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

Active Ingredients

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

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

Warnings

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
  • 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.

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

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

Active Ingredients (Active ingredients)

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

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

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