Fruit Of The Earth Sun Town City Dark Tanning Dry Oil Spf 8 Continuous Spray Sunscreen

Fruit Of The Earth Sun Town City Dark Tanning Dry Oil Spf 8 Continuous Spray Sunscreen
SPL v2
SPL
SPL Set ID c7a94f68-a4d5-ec82-e053-2995a90a38fb
Route
TOPICAL
Published
Effective Date 2019-11-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (70 mg) Octisalate (50 mg)
Inactive Ingredients
Alcohol Tridecyl Salicylate Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (75000 Mw) Mineral Oil .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-11-27

Description

Homosalate 7.0%, Octisalate 5.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 7.0%, Octisalate 5.0%

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 casued by the sun

Section 51945-4

Warnings

For external use only

Directions
  • Spray liberally and spread evenly by hand 15 minutes before sun exposure
  • Hold can 4-6 inches away from the skin to apply
  • Do not spray directly into face. Spray into 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 of age: Ask a doctor
  • 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 value of 15 or higher and other sun protection measures including:

• limit time in the sun, expecially from 10 a.m.-2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

Flammable:
  • do not use near heat, flame or while smoking
  • avoid long term storage above 104°F (40°C)
do Not Use

• on damaged or broken skin.

Other Information
  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Active Ingredients

Homosalate 7.0%, Octisalate 5.0%

Inactive Ingredients

alcohol denat., mineral oil, tridecyl salicylate, acrylates/octylacrylamide copolymer, tocopheryl acetate, fragrance.

when Using This Product

• keep out of eyes. Rinse with water to remove. • keep away from face to avoid breathing it. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120°F.

keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

stop Use and Ask A Doctor If

• rash occurs.


Structured Label Content

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 casued by the sun

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

Directions
  • Spray liberally and spread evenly by hand 15 minutes before sun exposure
  • Hold can 4-6 inches away from the skin to apply
  • Do not spray directly into face. Spray into 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 of age: Ask a doctor
  • 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 value of 15 or higher and other sun protection measures including:

• limit time in the sun, expecially from 10 a.m.-2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

Flammable:
  • do not use near heat, flame or while smoking
  • avoid long term storage above 104°F (40°C)
do Not Use (Do not use)

• on damaged or broken skin.

Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Active Ingredients

Homosalate 7.0%, Octisalate 5.0%

Inactive Ingredients (Inactive ingredients)

alcohol denat., mineral oil, tridecyl salicylate, acrylates/octylacrylamide copolymer, tocopheryl acetate, fragrance.

when Using This Product (When using this product)

• keep out of eyes. Rinse with water to remove. • keep away from face to avoid breathing it. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120°F.

keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• rash occurs.


Advanced Ingredient Data


Raw Label Data

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