SPL v3
SPL
SPL Set ID 49e256bf-f6aa-4aae-b792-cafdfe6ff43a
Route
TOPICAL
Published
Effective Date 2015-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (15 mg) Homosalate (150 mg) Octisalate (50 mg) Octocrylene (12.5 mg) Oxybenzone (60 mg)
Inactive Ingredients
C10-30 Cholesterol/lanosterol Esters Aloe Vera Leaf N-butylphthalimide Isopropylphthalimide Alkyl (c12-15) Benzoate Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Edetate Disodium Hypromelloses Methylisothiazolinone Methylparaben High Density Polyethylene Polyhydroxystearic Acid (2300 Mw) Polysorbate 20 Propylene Glycol Propylparaben Peg-6 Sorbitan Oleate Cocoa Butter .alpha.-tocopherol Acetate Trolamine Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-03-12
Description

Avobenzone 1.5%, Homosalate 15%, Octisalate 5%, Octocrylene 1.25%, and Oxybenzone 6%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 1.5%, Homosalate 15%, Octisalate 5%, Octocrylene 1.25%, and 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 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 60561-8

For external use only.

Warnings

Directions:

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 & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher & 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 from excesive heat & direct sunlight
Active Ingredients

Avobenzone 1.5%, Homosalate 15%, Octisalate 5%, Octocrylene 1.25%, and Oxybenzone 6%

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  237 ml  bottle Label

FAIR

&

SQUARE

SPORT

SUNSCREEN

Lotion With

Endurance Formula

50

Broad Spectrum

SPF 50

UVA/UVB Protection

Water Resistant (80 minutes)

Oil-Free, Non-Greasy Formula

Compare to Banana Boat

8 FL OZ (237mL)

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 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 60561-8 (60561-8)

For external use only.

Purpose

Sunscreen

Warnings

Directions:

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 & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher & 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 from excesive heat & direct sunlight
Active Ingredients (Active ingredients)

Avobenzone 1.5%, Homosalate 15%, Octisalate 5%, Octocrylene 1.25%, and Oxybenzone 6%

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  237 ml  bottle Label (PRINCIPAL DISPLAY PANEL - 237 mL  Bottle Label)

FAIR

&

SQUARE

SPORT

SUNSCREEN

Lotion With

Endurance Formula

50

Broad Spectrum

SPF 50

UVA/UVB Protection

Water Resistant (80 minutes)

Oil-Free, Non-Greasy Formula

Compare to Banana Boat

8 FL OZ (237mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:01.169634 · Updated: 2026-03-14T22:55:52.022027