SPL v4
SPL
SPL Set ID 245edcdc-4414-43f7-bf83-e16fc3310f3a
Route
TOPICAL
Published
Effective Date 2014-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (9.9 mg) Octocrylene (8.4 mg)
Inactive Ingredients
Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Aloe Vera Leaf 3-butylphthalide Isopropylphthalimide Alkyl (c12-15) Benzoate Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Edetate Disodium Methylisothiazolinone Methylparaben Hypromelloses Polysorbate 20 High Density Polyethylene Propylene Glycol Propylparaben Sorbitan Monooleate .alpha.-tocopherol Acetate Trolamine Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-02-04

Description

Avobenzone 1 %, Octocrylene 0.85 %


Medication Information

Description

Avobenzone 1 %, Octocrylene 0.85 %

Uses
  • helps prevent sunburn

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 53413-1

Questions or Comments?

Biocycle Laboratories, Inc.

16363 NW 49 Avenue, Miami, FL 33014

Section 55105-1

Purpose

Sunscreen

Section 60561-8

For external use only

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hour
  • children under 6 months: Ask a doctor
Other Information
  • protect this product from excesive heat and direct sun

Active Ingredients

Avobenzone 1 %, Octocrylene 0.85 %

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Fragrance (Parfum), Hydroxypropyl Methylcellulose, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Polyethylene, Polysorbate 20, Propylene Glycol, Propylparaben, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

Principal Display Panel  177 ml  can Label

Suntone

Fit for the sun

Sunscreen Lotion

Broad Spectrum SPF 4

Water Resistant (80 minutes)

Non-Greasy Formula

4

6 FL. OZ /177mL


Structured Label Content

Uses
  • helps prevent sunburn

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 53413-1 (53413-1)

Questions or Comments?

Biocycle Laboratories, Inc.

16363 NW 49 Avenue, Miami, FL 33014

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 60561-8 (60561-8)

For external use only

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hour
  • children under 6 months: Ask a doctor
Other Information (Other information)
  • protect this product from excesive heat and direct sun

Active Ingredients (Active ingredients)

Avobenzone 1 %, Octocrylene 0.85 %

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Fragrance (Parfum), Hydroxypropyl Methylcellulose, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Polyethylene, Polysorbate 20, Propylene Glycol, Propylparaben, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

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

Suntone

Fit for the sun

Sunscreen Lotion

Broad Spectrum SPF 4

Water Resistant (80 minutes)

Non-Greasy Formula

4

6 FL. OZ /177mL


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)