Milani Spf Bff 30 Primer

Milani Spf Bff 30 Primer
SPL v3
SPL
SPL Set ID c7a1f2a7-d299-2116-e053-2995a90ad8c5
Route
TOPICAL
Published
Effective Date 2021-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octinoxate (73 mg) Octocrylene (20 mg) Oxybenzone
Inactive Ingredients
Water Glycerin Isohexadecane Sodium Acrylate Sodium Acryloyldimethyltaurate Polyethylene Glycol 400 Polysorbate 80 Xanthan Gum Tocopherol Soybean Oil Vitamin A Palmitate Ethylhexylglycerin Citric Acid Monohydrate Edetate Disodium Anhydrous Phenoxyethanol Fd&c Yellow No. 5 Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-01

Description

Avobenzone 3%, Octinoxate 7.3% Octocrylene 3% Oxybenzone 2%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Octinoxate 7.3% Octocrylene 3% Oxybenzone 2%

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

Directions
  • apply generously and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor.
  •  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: Sun Protection Measures.
  • limit time in the sun, especially from 10 a.m.-2 p.m.
  • wear long-sleeved shirts, pants, and sunglasses
Do Not Use

on damaged or broken skin

Drug Facts

Other Information
  • Protect the product in this container from excessive heat and direct sun

Package Labeling:

Active Ingredients

Avobenzone 3%, Octinoxate 7.3% Octocrylene 3% Oxybenzone 2%





Inactive Ingredients:

Water, Glycerin, Isohexadecane, Sodium Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, PEG-8, Polysorbate 80, Xanthan Gum, Tocopherol, Glycine Soja (Soybean) Oil, Retinyl Palmitate, Ethylhexylglycerin, Citric Acid, Disodium EDTA, Phenoxyethanol, Yellow 5, Red 40.

Questions Or Comments?

Call 866-789-8002 Monday - Friday (7 a.m. to 3:30 p.m. PST)

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

Directions
  • apply generously and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor.
  •  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: Sun Protection Measures.
  • limit time in the sun, especially from 10 a.m.-2 p.m.
  • wear long-sleeved shirts, pants, and sunglasses
Do Not Use (Do not use)

on damaged or broken skin

Drug Facts

Other Information (Other information)
  • Protect the product in this container from excessive heat and direct sun

Package Labeling:

Active Ingredients (Active ingredients)

Avobenzone 3%, Octinoxate 7.3% Octocrylene 3% Oxybenzone 2%





Inactive Ingredients: (Inactive ingredients:)

Water, Glycerin, Isohexadecane, Sodium Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, PEG-8, Polysorbate 80, Xanthan Gum, Tocopherol, Glycine Soja (Soybean) Oil, Retinyl Palmitate, Ethylhexylglycerin, Citric Acid, Disodium EDTA, Phenoxyethanol, Yellow 5, Red 40.

Questions Or Comments? (Questions or comments?)

Call 866-789-8002 Monday - Friday (7 a.m. to 3:30 p.m. PST)

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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