Spf30 Sunscreen Lotion

Spf30 Sunscreen Lotion
SPL v5
SPL
SPL Set ID cac6f5e5-91c2-4978-bffd-5ca2a7590637
Route
TOPICAL
Published
Effective Date 2018-09-19
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
Dimethicone Caprylyl Glycol Phenoxyethanol Glyceryl Monostearate Vinylpyrrolidone/hexadecene Copolymer Levomenol Carboxypolymethylene Trolamine Edetate Disodium Anhydrous Coconut Water Glycerin Medium-chain Triglycerides Potassium Cetyl Phosphate Cetostearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-07-01

Description

​Avobenzone 3%, Homostate 10%, Octocrylene 10%, Octisalate 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

​Avobenzone 3%, Homostate 10%, Octocrylene 10%, Octisalate 5%

Uses
  • Helps prevent sunburn
Label

Warnings:

Spending time in the sun increases your risk of skin cnacer 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

  • 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
  • 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including: •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.

Questions?

Call toll free

Other Information

• Protect this product from excessive heat and direct sun

Active Ingredients

​Avobenzone 3%,

Homostate 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

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.

Package Labeling: (35ml 70412 231 35)


Structured Label Content

Uses
  • Helps prevent sunburn
Label

Purpose

Sunscreen

Warnings: (WARNINGS:)

Spending time in the sun increases your risk of skin cnacer 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

  • 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
  • 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including: •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.

Questions?

Call toll free

Other Information (Other information)

• Protect this product from excessive heat and direct sun

Active Ingredients

​Avobenzone 3%,

Homostate 10%,

Octocrylene 10%,

Octisalate 5%

Inactive Ingredients. (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

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.

Package Labeling: (35ml 70412 231 35) (Package Labeling: (35mL 70412-231-35))


Advanced Ingredient Data


Raw Label Data

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