botanical sunscreen broad spectrum spf 30 natural

botanical sunscreen broad spectrum spf 30 natural
SPL v3
SPL
SPL Set ID d1f44729-015a-4528-e053-2995a90af634
Route
topical
Published
Effective Date 2016-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (25.44 mg) homosalate (84.8 mg) octisalate (42.4 mg) octocrylene (23.32 mg)
Inactive Ingredients
butyl acrylate/c16-c20 alkyl methacrylate/methacrylic acid/methyl methacrylate copolymer alcohol polyester-8 (1400 mw, cyanodiphenylpropenoyl capped) porphyra umbilicalis kakadu plum .alpha.-tocopherol acetate water eucalyptus globulus leaf glycerin

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
otc monograph final active Since 2020-03-17

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 2.75%


Medication Information

Warnings

For external use only

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.
Purpose

Sunscreen

Directions
  • shake well before use
  • Apply liberally 15 minutes before sun exposure and rub into skin
  • 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 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 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 excessive heat and direct sun
  • Avoid spraying on fabrics - could cause discoloration
Inactive Ingredients

Eucalyptus Globulus Leaf Extract, Fragrance, Glycerin, Polyester-8, Porphyra Umbilicalis Extract, SD Alcohol 40-B, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 2.75%

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 60561-8

Flammable: Avoid fire, flame, heat and smoking. Contents under presssure. Do not puncture or incinerate. Store at temperatures below 120ºC (48ºC).

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.75%

Question Or Comments?

Call toll free 1-855-LIV-GOLD (548-4653)

Botanical Sunscreen Broad Spectrum Spf 30 Natural


Structured Label Content

Warnings

For external use only

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.
Purpose

Sunscreen

Directions
  • shake well before use
  • Apply liberally 15 minutes before sun exposure and rub into skin
  • 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 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 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 excessive heat and direct sun
  • Avoid spraying on fabrics - could cause discoloration
Inactive Ingredients

Eucalyptus Globulus Leaf Extract, Fragrance, Glycerin, Polyester-8, Porphyra Umbilicalis Extract, SD Alcohol 40-B, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, 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 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 60561-8 (60561-8)

Flammable: Avoid fire, flame, heat and smoking. Contents under presssure. Do not puncture or incinerate. Store at temperatures below 120ºC (48ºC).

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.75%

Question Or Comments? (Question or comments?)

Call toll free 1-855-LIV-GOLD (548-4653)

Botanical Sunscreen Broad Spectrum Spf 30 Natural (Botanical Sunscreen Broad Spectrum SPF 30 Natural)


Advanced Ingredient Data


Raw Label Data

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