Defense Total High Protection Spf 50 No Color Daily Non-greasy Face Protection

Defense Total High Protection Spf 50 No Color Daily Non-greasy Face Protection
SPL v3
SPL
SPL Set ID a7d69691-cecc-798e-e053-2a95a90a995f
Route
TOPICAL
Published
Effective Date 2020-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (8 g) Avobenzone (3 g) Homosalate (10 g)
Inactive Ingredients
Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Phenoxyethanol Polymethylsilsesquioxane (4.5 Microns) Xanthan Gum Cetostearyl Alcohol Edetate Disodium Anhydrous Physalis Angulata Whole Medium-chain Triglycerides Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) .alpha.-tocopherol Acetate Citric Acid Monohydrate Caprylyl Glycol Phenethyl Benzoate Vinylpyrrolidone/eicosene Copolymer Potassium Cetyl Phosphate Water Alkyl (c12-15) Benzoate Propylene Glycol Dimethicone Trimethylsiloxysilicate (m/q 0.6-0.8) Cetyl Palmitate Cyclomethicone 6

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-29

Description

Homosalate 10.00% Octocrylene 8.00% Avobenzone 3.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 10.00% Octocrylene 8.00% Avobenzone 3.00%

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 caused by the sun.
Warnings

For external use only.

Directions
  • Apply liberally and evenly 15 minutes before sun exposure
  • Reapply after 40 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
Product Packaging

Active Ingredients

Homosalate 10.00%

Octocrylene 8.00%

Avobenzone 3.00%

Company Information

PUERTO RICO: Dist. by Ventura Corp. Ltd., San Juan, Puerto Rico 00926.

Made in Colombia.

U.S.A.: Dist. by Ventura Int Ltd. DBA Belcorp USA, Miami, FL 33126.

Lnactive Ingredients

Water, styrene/acrylates copolymer, potassium cetyl phosphate, c12·15 alkyl benzoate, cyclohexasiloxane, dimethicone, phenethyl benzoate, polymethylsilsesquioxane, propylene glycol, vp/eicosene copolymer, trimethylsiloxysilicate, phenoxyethanol, cetyl palmitate, xanthan gum, physalis angulata extract, caprylic/capric triglyceride, xanthan gum, cetearyl alcohol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, acrylates/c10·30 alkyl acrylate crosspolymer, caprylyl glycol, disodium edta, tocopheryl acetate, citric acid

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 product is swallowed, get medical help or contact a Poison Control Center right away


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 caused by the sun.
Purpose

Sunscreen

Warnings

For external use only.

Directions
  • Apply liberally and evenly 15 minutes before sun exposure
  • Reapply after 40 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
Product Packaging

Active Ingredients (Active ingredients)

Homosalate 10.00%

Octocrylene 8.00%

Avobenzone 3.00%

Company Information

PUERTO RICO: Dist. by Ventura Corp. Ltd., San Juan, Puerto Rico 00926.

Made in Colombia.

U.S.A.: Dist. by Ventura Int Ltd. DBA Belcorp USA, Miami, FL 33126.

Lnactive Ingredients (lnactive ingredients)

Water, styrene/acrylates copolymer, potassium cetyl phosphate, c12·15 alkyl benzoate, cyclohexasiloxane, dimethicone, phenethyl benzoate, polymethylsilsesquioxane, propylene glycol, vp/eicosene copolymer, trimethylsiloxysilicate, phenoxyethanol, cetyl palmitate, xanthan gum, physalis angulata extract, caprylic/capric triglyceride, xanthan gum, cetearyl alcohol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, acrylates/c10·30 alkyl acrylate crosspolymer, caprylyl glycol, disodium edta, tocopheryl acetate, citric acid

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 product is swallowed, get medical help or contact a Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

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