Sei Bella Tinted Bb Moisturizing Creme Medium To Deep 500 W

Sei Bella Tinted Bb Moisturizing Creme Medium To Deep 500 W
SPL v3
SPL
SPL Set ID 68e30231-4fba-35d4-e053-2991aa0a33cb
Route
TOPICAL
Published
Effective Date 2018-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (1.5 g) Titanium Dioxide
Inactive Ingredients
Camellia Oleifera Leaf Tetrahexyldecyl Ascorbate Octyldodecanol Boron Nitride Dextrin Palmitate (corn; 20000 Mw) Stearic Acid Panax Ginseng Root Oil Matricaria Chamomilla Flowering Top Oil Triethoxycaprylylsilane Aluminum Hydroxide Glycerin Hexylene Glycol Butylene Glycol Octyldodecyl Neopentanoate Potassium Chloride Sodium Chloride Zinc Chloride Lysine Tocopherol Ascorbic Acid Dimethicone Ginkgo Biloba Leaf Oil Phytantriol Palmitic Acid Methicone (20 Cst) Sodium Dehydroacetate Caprylyl Glycol Phenoxyethanol Potassium Sorbate Peg/ppg-18/18 Dimethicone Water Magnesium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-05-01

Description

Titanium Dioxide 5% Zinc Oxide 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 5% Zinc Oxide 5%

Use
  • 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.
Section 44425-7
  • protect this product from excesssive heat and direct sun
  • do not store at temperatures below 32°F (0°C) or above 120°F (49°C)
Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Section 51945-4

Warnings

For external use only

Directions
  • apply smoothly on cleansed skin
  • 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 you 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-sleeve shirts, pants, hats, and sunglasses

Active Ingredient

Titanium Dioxide 5%

Zinc Oxide 5%

Other Information
  • for normal to oily skin
  • dermatologist tested
  • may stain some fabrics
Inactive Ingredients

Water (Aqua), Cyclopentasiloxane, Butylene Glycol, Octyldodecyl Neopentanoate, PEG/PPG-18/18 Dimethicone, Dimethicone, Magnesium Chloride, Potassium Chloride, Sodium Chloride, Zinc Chloride, Lysine, Tocopherol, Tetrahexyldecyl Ascorbate, Magnesium Ascorbyl Phosphate, Retinyl Palmitate, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Octyldodecanol, Sodium Hyaluronate, Phytantriol, Glycerin, Triethoxycaprylylsilane, Boron Nitride, Dextrin Palmitate, Palmitic Acid, Methicone, Stearic Acid, Aluminum Hydroxide, Hexylene Glycol, Disodium EDTA, Potassium Sorbate, Sodium Dehydroacetate, Caprylyl Glycol, Phenoxyethanol

May Contain (+/-): Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

Keep Out of Reach of Children.

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


Structured Label Content

Use
  • 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.
Section 44425-7 (44425-7)
  • protect this product from excesssive heat and direct sun
  • do not store at temperatures below 32°F (0°C) or above 120°F (49°C)
Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

Directions
  • apply smoothly on cleansed skin
  • 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 you 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-sleeve shirts, pants, hats, and sunglasses

Active Ingredient

Titanium Dioxide 5%

Zinc Oxide 5%

Other Information (Other information)
  • for normal to oily skin
  • dermatologist tested
  • may stain some fabrics
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cyclopentasiloxane, Butylene Glycol, Octyldodecyl Neopentanoate, PEG/PPG-18/18 Dimethicone, Dimethicone, Magnesium Chloride, Potassium Chloride, Sodium Chloride, Zinc Chloride, Lysine, Tocopherol, Tetrahexyldecyl Ascorbate, Magnesium Ascorbyl Phosphate, Retinyl Palmitate, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Octyldodecanol, Sodium Hyaluronate, Phytantriol, Glycerin, Triethoxycaprylylsilane, Boron Nitride, Dextrin Palmitate, Palmitic Acid, Methicone, Stearic Acid, Aluminum Hydroxide, Hexylene Glycol, Disodium EDTA, Potassium Sorbate, Sodium Dehydroacetate, Caprylyl Glycol, Phenoxyethanol

May Contain (+/-): Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

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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