Sunscreen Spf 30

Sunscreen Spf 30
SPL v3
SPL
SPL Set ID af9aa56d-2f8a-55b9-e053-2a95a90a3258
Route
TOPICAL
Published
Effective Date 2020-09-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octocrylene (50 mg) Octisalate
Inactive Ingredients
Water Glycerin Medium-chain Triglycerides Potassium Cetyl Phosphate Cetostearyl Alcohol Dimethicone Caprylyl Glycol Phenoxyethanol Glyceryl Monostearate Vinylpyrrolidone/hexadecene Copolymer Levomenol Carbomer Homopolymer, Unspecified Type Trolamine Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-09-18

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

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

Uses
  • Helps prevent sunburn
Warnings:

Spending time in the sun increases your risk of skin cancer or early skin aging. This product has been shown only to prevent sunburn skin cancer or early skin aging. This product is water resistant or sweat resistant. Skin Cancer/Skin Aging Alert: NOT NOT

For external use only.

Directions

Non-Water Resistant Product

Spending time in the sun increases our risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measuress including: Sun Protection Measures.

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating 
  • Reapply at least every 2 hours
  • Children under 6 months: Ask a doctor
  • Limit time in the sun, especially from 10 a.m. to 2 p.m.
  • Wear long sleeve shirts, pants, hats and sunglasses.
Do Not Use

on damaged or broken skin.

Other Information
  • Protect this product from excessive heat and direct sun
Active Ingredients

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

Inactive Ingredients

Water, Glycerin, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol, Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolymer, Bisabolol, Carbomer, Fragrance, Triethanolamine, Disodium EDTA

Package Labeling:30ml

Package Labeling:53ml

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
Purpose

Sunscreen

Warnings: (WARNINGS:)

Spending time in the sun increases your risk of skin cancer or early skin aging. This product has been shown only to prevent sunburn skin cancer or early skin aging. This product is water resistant or sweat resistant. Skin Cancer/Skin Aging Alert: NOT NOT

For external use only.

Directions

Non-Water Resistant Product

Spending time in the sun increases our risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measuress including: Sun Protection Measures.

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating 
  • Reapply at least every 2 hours
  • Children under 6 months: Ask a doctor
  • Limit time in the sun, especially from 10 a.m. to 2 p.m.
  • Wear long sleeve shirts, pants, hats and sunglasses.
Do Not Use (Do not use)

on damaged or broken skin.

Other Information
  • Protect this product from excessive heat and direct sun
Active Ingredients

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

Inactive Ingredients

Water, Glycerin, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol, Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolymer, Bisabolol, Carbomer, Fragrance, Triethanolamine, Disodium EDTA

Package Labeling:30ml

Package Labeling:53ml

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor  (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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