SPL v3
SPL
SPL Set ID 8e8f707b-734c-4bd3-bac5-951f647f37b9
Route
TOPICAL
Published
Effective Date 2013-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (25.6 mg) Homosalate (106.8 mg) Octisalate (42.7 mg) Octocrylene (23.5 mg) Oxybenzone (51.2 mg)
Inactive Ingredients
Diethylhexyl 2,6-naphthalate Alcohol Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped)

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-02-21
Description

Avobenzone 3 %, Homosalate 12.5 %, Octisalate 5 %, Octocrylene 2.75 %,  Oxybenzone 6 %

Medication Information

Description

Avobenzone 3 %, Homosalate 12.5 %, Octisalate 5 %, Octocrylene 2.75 %,  Oxybenzone 6 %

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 53413-1

Questions or Comments?

Call toll free 1-800-840-5225

Section 55105-1

Purpose

Sunscreen

Section 60561-8

For external use only

Warnings

Directions
  • spray liberally and spread by hand 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 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
  • 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.
Other Information
  • protect this product from excesive heat and direct sun. May stain some fabrics
Active Ingredients

Avobenzone 3 %, Homosalate 12.5 %, Octisalate 5 %, Octocrylene 2.75 %,  Oxybenzone 6 %

Inactive Ingredients

Diethylhexyl 2,6-Naphthalate, Fragrance, Polyester-8, SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Principal Display Panel 177 Ml Can Label

Panama Jack

SPF

70

BROAD SPECTRUM SPF 70

CONTINUOUS CLEAR

SUNSCREEN SPRAY

WATER RESISTANT (80 MINUTES)

NON-GREASY FORMULA

QUICK & EVEN COVERAGE

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.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 53413-1 (53413-1)

Questions or Comments?

Call toll free 1-800-840-5225

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 60561-8 (60561-8)

For external use only

Warnings

Directions
  • spray liberally and spread by hand 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 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
  • 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.
Other Information (Other information)
  • protect this product from excesive heat and direct sun. May stain some fabrics
Active Ingredients (Active ingredients)

Avobenzone 3 %, Homosalate 12.5 %, Octisalate 5 %, Octocrylene 2.75 %,  Oxybenzone 6 %

Inactive Ingredients

Diethylhexyl 2,6-Naphthalate, Fragrance, Polyester-8, SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

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

Panama Jack

SPF

70

BROAD SPECTRUM SPF 70

CONTINUOUS CLEAR

SUNSCREEN SPRAY

WATER RESISTANT (80 MINUTES)

NON-GREASY FORMULA

QUICK & EVEN COVERAGE

6 FL OZ (177 mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:01.220824 · Updated: 2026-03-14T22:55:52.022027