SPL v3
SPL
SPL Set ID 6e5d321d-0f7e-45be-aaeb-52161904f172
Route
TOPICAL
Published
Effective Date 2015-02-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (25.2 mg) Homosalate (63 mg) Octisalate (42 mg) Octocrylene (23.1 mg) Oxybenzone (16.8 mg)
Inactive Ingredients
Alcohol Butyl Maleurate .alpha.-tocopherol Acetate Isobornyl Acrylate

Identifiers & Packaging

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

Description

Avobenzone 3 %, Homosalate 7.5%, Octisalate 5 %,  Octocrylene 2.75 %, and Oxybenzone 2 %

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3 %, Homosalate 7.5%, Octisalate 5 %,  Octocrylene 2.75 %, and Oxybenzone 2 %

Uses
  • helps prevent sunburn
  • If use 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 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 away from face to avoid breathing it
  • 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?

SolScents, LLC.2200 N.W. 92nd Avenue. Miami, Florida 33172

Section 60561-8

For external use only

Warnings

Directions
  • spray liberally and spread evenly by hand 15 minutes before sun exposure. Ensure skin is completely covered with product
  • hold container 4-6 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
  • Sun Protection Measures. Spending time in the sun increases your risk of skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and othe 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
  • avoid spraying on fabrics could cause discoloration
  • protect this product from exessive heat and direct sun
Active Ingredients

Avobenzone 3 %, Homosalate 7.5%, Octisalate 5 %,  Octocrylene 2.75 %, and Oxybenzone 2 %

Inactive Ingredients

Fragrance (Parfum), SD Alcohol 40-B, tocopheryl acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Principal Display Panel 177 Ml Can Label

SolScents

Sunscreen

Broad spectrum SPF 30

Skin Nourishing Antioxidants

Deep Love

Sugares Plums & Freesia

30

Continuous Spray Sunscreen

Water Resistant (80 Minutes)

MADE IN THE USA

6 FL OZ (177 mL)


Structured Label Content

Uses
  • helps prevent sunburn
  • If use 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 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 away from face to avoid breathing it
  • 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?

SolScents, LLC.2200 N.W. 92nd Avenue. Miami, Florida 33172

Section 60561-8 (60561-8)

For external use only

Purpose

Sunscreen

Warnings

Directions
  • spray liberally and spread evenly by hand 15 minutes before sun exposure. Ensure skin is completely covered with product
  • hold container 4-6 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
  • Sun Protection Measures. Spending time in the sun increases your risk of skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and othe 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
  • avoid spraying on fabrics could cause discoloration
  • protect this product from exessive heat and direct sun
Active Ingredients (Active ingredients)

Avobenzone 3 %, Homosalate 7.5%, Octisalate 5 %,  Octocrylene 2.75 %, and Oxybenzone 2 %

Inactive Ingredients

Fragrance (Parfum), SD Alcohol 40-B, tocopheryl acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

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

SolScents

Sunscreen

Broad spectrum SPF 30

Skin Nourishing Antioxidants

Deep Love

Sugares Plums & Freesia

30

Continuous Spray Sunscreen

Water Resistant (80 Minutes)

MADE IN THE USA

6 FL OZ (177 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)