SPL v3
SPL
SPL Set ID 82c56c45-1f18-418d-946b-d320b9369258
Route
TOPICAL
Published
Effective Date 2015-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (49.35 mg) Octisalate (49.35 1) Octocrylene (19.74 1) Zinc Cation (29.61 mg)
Inactive Ingredients
Hexyl Laurate Polyglyceryl-4 Isostearate Diazolidinyl Urea Triethoxycaprylylsilane Methylparaben Propylparaben Silicon Dioxide Sodium Chloride .alpha.-tocopherol Acetate Water Aluminum Starch Octenylsuccinate Bis-peg-10 Dimethicone/dimer Dilinoleate Copolymer Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Decyl Glucoside Diisodecyl Adipate Glycerin Hydrogenated Castor Oil Mineral Oil Edetate Disodium High Density Polyethylene

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-12-29

Description

Active ingredients Octinoxate 5%, Octisalate 5%, Octocrylene 2%, Zinc Oxide 3%

Purpose

Sunscreen


Medication Information

Warnings and Precautions

Warnings For external use only Do not use on damaged or broken skin • When using this productkeep out of eyes. Rinse with water to remove. • Stop use and ask a doctorif rash occurs. • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

UsesHelps 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

Dosage and Administration

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 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.

Description

Active ingredients Octinoxate 5%, Octisalate 5%, Octocrylene 2%, Zinc Oxide 3%

Section 55106-9

Active ingredients Octinoxate 5%, Octisalate 5%, Octocrylene 2%, Zinc Oxide 3%

Section 60561-8

Other information Protect this product from excessive heat and direct sun

Distributed by: Panama Jack, Inc. Orlando, FL. 32801 1-800-840-5225

Inactive Ingrediets

Aluminium Starch Octenylsuccinate, Bis-PEG-12 Dimethicone Beeswax, Cetyl PEG/PPG-10/1 Dimethicone, Decyl Glucoside, Diazolidinyl Urea, Diisodecyl Adipate, Disodium EDTA, Glycerin, Hexyl Laurate, Hydrogenated Castor Oil, Methylparaben, Mineral Oil, Polyethylene, Polyglyceryl-4 Isostearate, Propylene Glycol, Propylparaben, Silica, Sodium Chloride, Tocopheryl Acetate, Triethoxycaprylysilane, Water

Principal Display Panel  30ml  bottle Label

Panama Jack

SUNSCREEN

LOTION

1 FL OZ (30mL)

30 BROAD SPECTRUM SPF 30

CLEAR ZINC

WATER RESISTANT (80 MINUTES)


Structured Label Content

Indications and Usage (34067-9)

UsesHelps 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

Dosage and Administration (34068-7)

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 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.

Warnings and Precautions (34071-1)

Warnings For external use only Do not use on damaged or broken skin • When using this productkeep out of eyes. Rinse with water to remove. • Stop use and ask a doctorif rash occurs. • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 55106-9 (55106-9)

Active ingredients Octinoxate 5%, Octisalate 5%, Octocrylene 2%, Zinc Oxide 3%

Section 60561-8 (60561-8)

Other information Protect this product from excessive heat and direct sun

Distributed by: Panama Jack, Inc. Orlando, FL. 32801 1-800-840-5225

Purpose

Sunscreen

Inactive Ingrediets

Aluminium Starch Octenylsuccinate, Bis-PEG-12 Dimethicone Beeswax, Cetyl PEG/PPG-10/1 Dimethicone, Decyl Glucoside, Diazolidinyl Urea, Diisodecyl Adipate, Disodium EDTA, Glycerin, Hexyl Laurate, Hydrogenated Castor Oil, Methylparaben, Mineral Oil, Polyethylene, Polyglyceryl-4 Isostearate, Propylene Glycol, Propylparaben, Silica, Sodium Chloride, Tocopheryl Acetate, Triethoxycaprylysilane, Water

Principal Display Panel  30ml  bottle Label (PRINCIPAL DISPLAY PANEL - 30mL  Bottle Label)

Panama Jack

SUNSCREEN

LOTION

1 FL OZ (30mL)

30 BROAD SPECTRUM SPF 30

CLEAR ZINC

WATER RESISTANT (80 MINUTES)


Advanced Ingredient Data


Raw Label Data

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