Farmasi Bb Cream

Farmasi Bb Cream
SPL v2
SPL
SPL Set ID 042817f9-675e-056a-e063-6394a90a2d97
Route
TOPICAL
Published
Effective Date 2023-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (29.5 mg) Octinoxate (73.5 mg) Homosalate (97.9 mg) Octocrylene (61.5 mg)
Inactive Ingredients
Water Alkyl (c12-15) Benzoate Peg-100 Stearate Glyceryl Monostearate Cetostearyl Alcohol Glycerin Silicon Dioxide Cyclomethicone 5 Polyoxyl 20 Cetostearyl Ether Dicaprylyl Carbonate Ethylhexyl Palmitate Phenoxyethanol Dimethicone Ethylhexylglycerin .alpha.-tocopherol Acetate Trehalose Urea Serine Pentylene Glycol Xanthan Gum Sodium Alginate Caprylyl Glycol Hyaluronate Sodium Pullulan Edetate Disodium Anhydrous Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-03

Description

Butyl Methoxydibenzoylmethane 2.95% Ethylhexyl Methoxycinnamate 7.35% Homosalate 9.79% Octocrylene 6.15%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Butyl Methoxydibenzoylmethane 2.95% Ethylhexyl Methoxycinnamate 7.35% Homosalate 9.79% Octocrylene 6.15%

Uses:
  • Helps prevent sunburn.
  • if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
Warnings:

For external use only.

Do Not Use

on damaged or broken skin.

Directions:

For Sunscreen Use

  • Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours.
  • Reapply atleast every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  •  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. Sun Protection Measures:
  • Limit time in the sun, especially from 10 a.m. – 2 p.m.,
  • wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months of age: Ask a doctor.
Drug Facts:

Package Labeling:

Active Ingredient:

Butyl Methoxydibenzoylmethane 2.95% Ethylhexyl Methoxycinnamate 7.35% Homosalate 9.79% Octocrylene 6.15%





Other Information:
  • Protect this product from excessive heat and direct sun. May stain some fabrics.
Inactive Ingredients:

Water/Aqua, C 12-15 Alkyl Benzoate, Peg-100 Stearate, Glyceryl Stearate, Cetearyl Alcohol, Glycerin, Silica, Cyclopentasiloxane, Ceteareth-20, Dicaprylyl Carbonate, Ethylhexyl Palmitate, Phenoxyethanol, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Tocopheryl Acetate, Trehalose, Urea, Serine, Pentylene Glycol, Xanthan Gum, Algin, Caprylyl Glycol, Sodium Hyaluronate, Pullulan, Disodium EDTA, Triethanolamine.

Questions Or Comments?

[email protected] (833) 432-7627

Monday - Friday (9 a.m - 9 p.m. EST)

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.
  • if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
Purpose

Sunscreen

Warnings:

For external use only.

Do Not Use (Do not use)

on damaged or broken skin.

Directions:

For Sunscreen Use

  • Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours.
  • Reapply atleast every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  •  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. Sun Protection Measures:
  • Limit time in the sun, especially from 10 a.m. – 2 p.m.,
  • wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months of age: Ask a doctor.
Drug Facts:

Package Labeling:

Active Ingredient:

Butyl Methoxydibenzoylmethane 2.95% Ethylhexyl Methoxycinnamate 7.35% Homosalate 9.79% Octocrylene 6.15%





Other Information:
  • Protect this product from excessive heat and direct sun. May stain some fabrics.
Inactive Ingredients:

Water/Aqua, C 12-15 Alkyl Benzoate, Peg-100 Stearate, Glyceryl Stearate, Cetearyl Alcohol, Glycerin, Silica, Cyclopentasiloxane, Ceteareth-20, Dicaprylyl Carbonate, Ethylhexyl Palmitate, Phenoxyethanol, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Tocopheryl Acetate, Trehalose, Urea, Serine, Pentylene Glycol, Xanthan Gum, Algin, Caprylyl Glycol, Sodium Hyaluronate, Pullulan, Disodium EDTA, Triethanolamine.

Questions Or Comments? (Questions or Comments?)

[email protected] (833) 432-7627

Monday - Friday (9 a.m - 9 p.m. EST)

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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