6055ba25-c346-4a18-bc72-ceac753f8a35

SPL v3
SPL
SPL Set ID 6055ba25-c346-4a18-bc72-ceac753f8a35
Route
topical
Published
Effective Date 2015-01-29
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 2014-04-10

Purpose

Sunscreen

Description

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


Medication Information

Warnings

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
Purpose

Sunscreen

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
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

Description

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

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

Active Ingredients

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

Principal Display Panel  237 ml  bottle Label

SOL

MATE

Love the Sun

SUNSCREEN LOTION

50

BROAD SPECTRUM SPF 50

WATER RESISTANT (80 MINUTES)

SHEER NON-GREASY FORMULA

8 FL.OZ./237mL


Structured Label Content

Warnings

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
Purpose

Sunscreen

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
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

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

Active Ingredients

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

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

SOL

MATE

Love the Sun

SUNSCREEN LOTION

50

BROAD SPECTRUM SPF 50

WATER RESISTANT (80 MINUTES)

SHEER NON-GREASY FORMULA

8 FL.OZ./237mL


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)