SPL v3
SPL
SPL Set ID 22bd3509-8193-4929-aac0-b36a426e4e6c
Route
TOPICAL
Published
Effective Date 2015-02-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (8.1 mg) Octisalate (24.3 mg) Octocrylene (6.885 mg) Oxybenzone
Inactive Ingredients
Alkyl (c12-15) Benzoate Alcohol Butyl Maleurate Isobornyl Acrylate

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-03-01
Description

Avobenzone 1 %, Octisalate 3 %,  Octocrylene 0.85 %, and Oxybenzone 1 %

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 1 %, Octisalate 3 %,  Octocrylene 0.85 %, and Oxybenzone 1 %

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.

 •Keep away from face to avoid breathing it.

•Contents under pressure-do not puncture or incinerate. Do not store at temperatures above 120°F

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 60561-8

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

For external use only

Warnings

Directions
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • 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 a well-ventilated area
  • reapply:
  • After 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months: Ask a doctor
Other Information

•protect this product from excessive heat and direct sun

 •may stain fabrics.

Active Ingredients

Avobenzone 1 %, Octisalate 3 %,  Octocrylene 0.85 %, and Oxybenzone 1 %

Inactive Ingredients

C12-15 Alkyl Benzoate, Fragrance (Parfum), SD Alcohol 40-B (Alcohol Denat.), VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Principal Display Panel 177 Ml Can Label

SOL

MATE

Love the Sun

Continuous Spray

Sunscreen

8

Broad Spectrum SPF 8

Water Resistant (80) Minutes

Non-Greasy Formula

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.

 •Keep away from face to avoid breathing it.

•Contents under pressure-do not puncture or incinerate. Do not store at temperatures above 120°F

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 60561-8 (60561-8)

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

For external use only

Purpose

Sunscreen

Warnings

Directions
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • 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 a well-ventilated area
  • reapply:
  • After 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months: Ask a doctor
Other Information

•protect this product from excessive heat and direct sun

 •may stain fabrics.

Active Ingredients (Active ingredients)

Avobenzone 1 %, Octisalate 3 %,  Octocrylene 0.85 %, and Oxybenzone 1 %

Inactive Ingredients

C12-15 Alkyl Benzoate, Fragrance (Parfum), SD Alcohol 40-B (Alcohol Denat.), VA/Butyl Maleate/Isobornyl Acrylate Copolymer

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

SOL

MATE

Love the Sun

Continuous Spray

Sunscreen

8

Broad Spectrum SPF 8

Water Resistant (80) Minutes

Non-Greasy Formula

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:01.102249 · Updated: 2026-03-14T22:55:50.118517