9038027c-b36b-484d-997b-7412f9afef46

SPL v3
SPL
SPL Set ID 9038027c-b36b-484d-997b-7412f9afef46
Route
topical
Published
Effective Date 2014-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (16.7 mg) homosalate (62.625 mg) octisalate (41.8 mg) octocrylene (22.9 mg) oxybenzone
Inactive Ingredients
diethylhexyl 2,6-naphthalate polyester-8 (1400 mw, cyanodiphenylpropenoyl capped) alcohol dibutyl maleate

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
otc monograph final active Since 2013-11-21
Description

Avobenzone 2 %, Homosalate 7.5 %, Octisalate  5 %, Octocrylene 2.75 %, and Oxybenzone 2 %

Medication Information

Warnings

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
Directions
  • spray liberally and evenly 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 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
  • 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
Inactive Ingredients

Diethylhexyl 2,6-Naphhalate, Fragrance (Parfum), Polyester-8, SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Description

Avobenzone 2 %, Homosalate 7.5 %, Octisalate  5 %, Octocrylene 2.75 %, and Oxybenzone 2 %

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

Active Ingredients

Avobenzone 2 %, Homosalate 7.5 %, Octisalate  5 %, Octocrylene 2.75 %, and Oxybenzone 2 %

Principal Display Panel  177 ml  bottle Label

Panama Jack

SPF 30

BROAD SPECTRUM SPF 30+

CONTINUOUS CLEAR

SUNSCREEN SPRAY

WATER RESISTANT (80 MINUTES)

NON-GREASY FORMULA

QUICK & EVEN COVERAGE

6 FL OZ (177 mL)

Structured Label Content

Warnings

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
Directions
  • spray liberally and evenly 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 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
  • 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
Inactive Ingredients

Diethylhexyl 2,6-Naphhalate, Fragrance (Parfum), Polyester-8, SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

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

Active Ingredients (Active ingredients)

Avobenzone 2 %, Homosalate 7.5 %, Octisalate  5 %, Octocrylene 2.75 %, and Oxybenzone 2 %

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

Panama Jack

SPF 30

BROAD SPECTRUM SPF 30+

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: 2026-02-15T11:57:01.224496 · Updated: 2026-03-14T22:55:52.022027