Fruit Of The Earth Sun Town City Dark Tanning Spf 8 Lotion Sunscreen

Fruit Of The Earth Sun Town City Dark Tanning Spf 8 Lotion Sunscreen
SPL v2
SPL
SPL Set ID c7aa1e58-f7b3-6b7f-e053-2995a90a957c
Route
TOPICAL
Published
Effective Date 2019-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (15 mg) Octisalate (50 mg) Octocrylene (60 mg)
Inactive Ingredients
Water Glycerin Octyldodecyl Neopentanoate Butyloctyl Salicylate Cetostearyl Alcohol Polysorbate 60 Dimethicone Phenoxyethanol Caprylyl Glycol Carbomer Interpolymer Type A (55000 Cps) Ethylhexylglycerin Trolamine Ethylene Brassylate Dipropylene Glycol 2,6-dimethyl-5-heptenal Glyceryl 1-stearate Peg-100 Stearate Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-12-09

Description

Avobenzone 1.5%, Octisalate 5.0%, Octocrylene 6.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 1.5%, Octisalate 5.0%, Octocrylene 6.0%

Uses

• helps prevent sunburn

Section 51945-4

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only

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

  • 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, especially from 10 a.m.-2 p.m.

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

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

Avobenzone 1.5%, Octisalate 5.0%, Octocrylene 6.0%

inactive Ingredients

water, octyldodecyl neopentanoate, glycerin, butyloctyl salicylate, cetearyl alcohol, polysorbate 60, glyceryl stearate, PEG-100 stearate, dimethicone, phenoxyethanol, ethylhexylglycerin, caprylyl glycol, carbomer, triethanolamine, disodium EDTA, ethylene brassylate, dipropylene glycol, dimethyl heptenal.

when Using This Product 

• keep out of eyes. Rinse with water to remove.

stop Use and Ask A Doctor If

• rash occurs.

keep Out of Reach of Children.

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


Structured Label Content

Uses

• helps prevent sunburn

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only

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

  • 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, especially from 10 a.m.-2 p.m.

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

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 (Active ingredients)

Avobenzone 1.5%, Octisalate 5.0%, Octocrylene 6.0%

inactive Ingredients (Inactive ingredients)

water, octyldodecyl neopentanoate, glycerin, butyloctyl salicylate, cetearyl alcohol, polysorbate 60, glyceryl stearate, PEG-100 stearate, dimethicone, phenoxyethanol, ethylhexylglycerin, caprylyl glycol, carbomer, triethanolamine, disodium EDTA, ethylene brassylate, dipropylene glycol, dimethyl heptenal.

when Using This Product  (When using this product )

• keep out of eyes. Rinse with water to remove.

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

• rash occurs.

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.


Advanced Ingredient Data


Raw Label Data

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