Sun Skin Spf50 Sunscreen

Sun Skin Spf50 Sunscreen
SPL v1
SPL
SPL Set ID 9819e603-8a87-408a-839d-e325493590aa
Route
ORAL
Published
Effective Date 2018-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (117 mg) Octisalate (45 mg) Oxybenzone (54 mg) Octocrylene
Inactive Ingredients
Propylene Glycol Water Polyurethane-34 (40 Mpa, Tensile Strength Of Film At Break) Cetyl Alcohol Potassium Cetyl Phosphate Glycerin Sorbitan Monostearate Polysorbate 60 Phenoxyethanol Ethylhexylglycerin Potassium Hydroxide Dimethicone .alpha.-tocopherol Acetate Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Arginine Sodium Ascorbyl Phosphate Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-06-11

Description

Sunscreen Uses ● helps prevent sunburn ● if used as directed with other sun protection measures decreases the risk of skin cancer and early skin aging caused by the sun 

Purpose

Sunscreen Uses ● helps prevent sunburn ● if used as directed with other sun protection measures decreases the risk of skin cancer and early skin aging caused by the sun 


Medication Information

Purpose

Sunscreen

Uses

● helps prevent sunburn

● if used as directed with other sun protection measures

  • decreases the risk of skin cancer and early skin aging caused by the sun 
Description

Sunscreen Uses ● helps prevent sunburn ● if used as directed with other sun protection measures decreases the risk of skin cancer and early skin aging caused by the sun 

Directions 

● apply generously 15 minutes before sun exposure

● ensure complete coverage to the are above the lip, nose, and tops of ears

● reapply: - after 80 minutes of swimming or sweating – immediately after towel drying – at least every 2 hours.

Product Label 

Ask Doctor Section

●If rash occurs, stop use and ask a doctor

Active Ingredients

Avobenzone 3%, Homosalate 11.7%,

Octisalate 4.5%, Oxybenzone 5.4%,

Octocrylene 4.5%

Inactive Ingredient

ingredients: water, propylene glycol,

polyurethane-34, cetyl alcohol, potassium cetyl

phosphate, glycerin, sorbitan mono stearate,

polysorbate 60, phenoxyethanol,

ethylhexylglycerin, potassium hydroxide,

dimethicone, tocopheryl acetate, acrylates/C10-

30 alkyl acrylate crosspolymer, arginine, sodium

ascorbyl phosphate, disodium EDTA

Warning and Pracaution

●For external use only

●Do not use on damaged or broken skin 

●When using this product  keep out of eyes. Rinse with water to remove.

●If rash  occurs, stop use and ask a doctor 

Keep Out of Reach of Children Section
  • KEEP OUT OF REACH OF CHILDREN SECTION
  • If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Purpose (PURPOSE)

Sunscreen

Uses

● helps prevent sunburn

● if used as directed with other sun protection measures

  • decreases the risk of skin cancer and early skin aging caused by the sun 
Directions 

● apply generously 15 minutes before sun exposure

● ensure complete coverage to the are above the lip, nose, and tops of ears

● reapply: - after 80 minutes of swimming or sweating – immediately after towel drying – at least every 2 hours.

Product Label 

Ask Doctor Section (ASK DOCTOR SECTION)

●If rash occurs, stop use and ask a doctor

Active Ingredients (Active ingredients)

Avobenzone 3%, Homosalate 11.7%,

Octisalate 4.5%, Oxybenzone 5.4%,

Octocrylene 4.5%

Inactive Ingredient (INACTIVE INGREDIENT)

ingredients: water, propylene glycol,

polyurethane-34, cetyl alcohol, potassium cetyl

phosphate, glycerin, sorbitan mono stearate,

polysorbate 60, phenoxyethanol,

ethylhexylglycerin, potassium hydroxide,

dimethicone, tocopheryl acetate, acrylates/C10-

30 alkyl acrylate crosspolymer, arginine, sodium

ascorbyl phosphate, disodium EDTA

Warning and Pracaution (WARNING AND Pracaution)

●For external use only

●Do not use on damaged or broken skin 

●When using this product  keep out of eyes. Rinse with water to remove.

●If rash  occurs, stop use and ask a doctor 

Keep Out of Reach of Children Section (KEEP OUT OF REACH OF CHILDREN SECTION)
  • KEEP OUT OF REACH OF CHILDREN SECTION
  • If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)