SPL v4
SPL
SPL Set ID 6053bc07-3060-4610-864d-d549df6dc926
Route
TOPICAL
Published
Effective Date 2015-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (29.7 mg) Homosalate (99 mg) Octisalate (49.5 mg) Octocrylene (27.225 mg) Oxybenzone
Inactive Ingredients
(c10-c30)alkyl Methacrylate Ester Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Aloe Vera Leaf N-butylphthalimide Isopropylphthalimide Alkyl (c12-15) Benzoate Caprylic/capric Acid Crambe Maritima Leaf Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Edetate Disodium Helianthus Annuus Seed Wax Hypromelloses Phenoxyethanol Ethylhexylglycerin High Density Polyethylene Polysorbate 20 Propylene Glycol Pseudopterogorgia Elisabethae .alpha.-tocopherol Acetate Apricot Kernel Oil Water Solanum Lycopersicum Sodium Hydroxide Peg-6 Sorbitan Oleate Cocoa Butter Corn Oil .beta.-carotene

Identifiers & Packaging

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

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

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

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

Section 50570-1

Do not use on damaged or broken skin

Section 60561-8

For external use only

Warnings

Directions
  • apply liberally 15 minutes before sun exposure
  • 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 our risk of skin cancer and earl 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 excesive heat and direct sun. •may stain fabrics.
Active Ingredients

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

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice,  Beta-Carotene, Butylphthalimide, C12-15 Alkyl Benzoate, Caprylic/ Capric Triglyceride, Carbomer, Crambe Maritima Extract, Disodium EDTA, Ethylhexyglycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Phenoxyethanol, Polyethylene, Polysorbate 20, Propylene Glycol, Propylene Glycol, Prunus Ameniaca (Apricot) Kernel Oil, Pseudopterogorgia Elisabethae Plant Extract, Sodium Hydroxide, Solanum Lycopersicum (Tomato) Fruit/Leaf/Steam Extract, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water (Aqua), Zea Mays (Corn) Oil

Questions Or Comments?

Call 305.471.7989

Principal Display Panel  177 ml  bottle Label

OFFICIAL SUNCARE

MB

MIAMIBEACH

MB LIFEGUARDS

KIDS

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

6 FL OZ (177mL)

OFFICIAL SUNCARE

MB

MIAMIBEACH

MB LIFEGUARDS

KIDS

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

0.25 FL OZ (7.4mL)


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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 60561-8 (60561-8)

For external use only

Purpose

Sunscreen

Warnings

Directions
  • apply liberally 15 minutes before sun exposure
  • 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 our risk of skin cancer and earl 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 (Other information)
  • protect this product from excesive heat and direct sun. •may stain fabrics.
Active Ingredients (Active ingredients)

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

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice,  Beta-Carotene, Butylphthalimide, C12-15 Alkyl Benzoate, Caprylic/ Capric Triglyceride, Carbomer, Crambe Maritima Extract, Disodium EDTA, Ethylhexyglycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Phenoxyethanol, Polyethylene, Polysorbate 20, Propylene Glycol, Propylene Glycol, Prunus Ameniaca (Apricot) Kernel Oil, Pseudopterogorgia Elisabethae Plant Extract, Sodium Hydroxide, Solanum Lycopersicum (Tomato) Fruit/Leaf/Steam Extract, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water (Aqua), Zea Mays (Corn) Oil

Questions Or Comments? (Questions or Comments?)

Call 305.471.7989

Principal Display Panel  177 ml  bottle Label (PRINCIPAL DISPLAY PANEL - 177 mL  Bottle Label)

OFFICIAL SUNCARE

MB

MIAMIBEACH

MB LIFEGUARDS

KIDS

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

6 FL OZ (177mL)

OFFICIAL SUNCARE

MB

MIAMIBEACH

MB LIFEGUARDS

KIDS

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

0.25 FL OZ (7.4mL)


Advanced Ingredient Data


Raw Label Data

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