SPL v3
SPL
SPL Set ID c3e3db90-8244-4c26-a1da-5f52b867c2d8
Route
TOPICAL
Published
Effective Date 2015-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (29.7 mg) Homosalate (99 mg) Octisalate (49.5 mg) Octocrylene (27.225 mg) Oxybenzone
Inactive Ingredients
(c10-c30)alkyl Methacrylate Ester Aloe Vera Leaf N-butylphthalimide Isopropylphthalimide Alkyl (c12-15) Benzoate Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Edetate Disodium Hypromelloses Methylparaben High Density Polyethylene Polysorbate 20 Propylene Glycol Propylparaben Sorbitan Monooleate Cocoa Butter .alpha.-tocopherol Acetate Trolamine Methylisothiazolinone Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-03-31
Description

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 3 %

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 3 %

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Dictections), 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?: Biocycle Laboratories, Inc.

16363 NW 49 Avenue, Miami, FL 33014

Section 60561-8

For external use only

Warnings

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
Other Information
  • protect this product from excesive heat and direct sun
Active Ingredients

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 3 %

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Fragrance, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Polyethylene, Polysorbate 20, Propylene Glycol, Propylparaben, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water

Principal Display Panel  237 ml  bottle Label

SOL

MATE

BABY

SUNSCREEN LOTION

50

BROAD SPECTRUM SPF 50

WATER RESISTANT (80 MINUTES)

SHEER NON-GREASY FORMULA

FRAGRANCE FREE

8 FL.OZ./237mL

Structured Label Content

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Dictections), 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?: Biocycle Laboratories, Inc.

16363 NW 49 Avenue, Miami, FL 33014

Section 60561-8 (60561-8)

For external use only

Purpose

Sunscreen

Warnings

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
Other Information (Other information)
  • protect this product from excesive heat and direct sun
Active Ingredients

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 3 %

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Fragrance, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Polyethylene, Polysorbate 20, Propylene Glycol, Propylparaben, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water

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

SOL

MATE

BABY

SUNSCREEN LOTION

50

BROAD SPECTRUM SPF 50

WATER RESISTANT (80 MINUTES)

SHEER NON-GREASY FORMULA

FRAGRANCE FREE

8 FL.OZ./237mL

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:01.720014 · Updated: 2026-03-14T22:55:52.022027