SPL v3
SPL
SPL Set ID acb1e9cd-3c98-4ff8-9ea0-94b1288d0fd3
Route
TOPICAL
Published
Effective Date 2014-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30.1 mg) Homosalate (100.2 mg) Octisalate (50.1 mg) Octocrylene (27.6 mg) Oxybenzone (20 mg)
Inactive Ingredients
Carbomer Copolymer Type A Butyl Acrylate/c16-c20 Alkyl Methacrylate/methacrylic Acid/methyl Methacrylate Copolymer Aloe Vera Leaf Aminomethylpropanol 3-butylphthalide Isopropylphthalimide Edetate Disodium Methylparaben Potassium Cetyl Phosphate Propylene Glycol Chamomile Water Propylparaben Sorbitol Butyl Methacrylate/methyl Methacrylate/methacrylic Acid/styrene Crosspolymer .alpha.-tocopherol Acetate Methylisothiazolinone

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-04-16

Description

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


Medication Information

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 0F
Section 50570-1

Do not use on damaged or broken skin.

Section 53413-1

Questions or Comments? Biocycle Laboratories, Inc.

16363 NW 49th Avenue, Miami, FL 33014

Section 55105-1

Purpose

Sunscreen

Section 60561-8

For external use only

Warnings

Directions
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • 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 well-ventilated areas.
  • 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 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 some 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 Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Butylphthalimide, Chamomilla Recutita (Matricaria) Flower Extract, Disodium EDTA, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Potassium Cetyl Phosphate, Propylene Glycol, Propylparaben, Sorbitol, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Water

Principal Display Panel  177 Ml Can Label



SOL

MATE

BABY

CONTINUOUS SPRAY

SUNSCREEN LOTION

50

BROAD SPECTRUM SPF 50

WATER RESISTANT (80 MINUTES)

NON-GREASY FORMULA

6 FL. OZ. / 177 mL


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 0F
Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 53413-1 (53413-1)

Questions or Comments? Biocycle Laboratories, Inc.

16363 NW 49th Avenue, Miami, FL 33014

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 60561-8 (60561-8)

For external use only

Warnings

Directions
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • 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 well-ventilated areas.
  • 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 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 some 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 Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Butylphthalimide, Chamomilla Recutita (Matricaria) Flower Extract, Disodium EDTA, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Potassium Cetyl Phosphate, Propylene Glycol, Propylparaben, Sorbitol, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Water

Principal Display Panel  177 Ml Can Label (PRINCIPAL DISPLAY PANEL - 177 mL Can Label)



SOL

MATE

BABY

CONTINUOUS SPRAY

SUNSCREEN LOTION

50

BROAD SPECTRUM SPF 50

WATER RESISTANT (80 MINUTES)

NON-GREASY FORMULA

6 FL. OZ. / 177 mL


Advanced Ingredient Data


Raw Label Data

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