OTC Medication Information: Sei Bella Tinted BB Moisturizing Creme Light to Medium 160 N

SEI BELLA TINTED BB MOISTURIZING CREME LIGHT TO MEDIUM 160 N- zinc oxide and titanium dioxide lotion
Melaleuca Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Titanium Dioxide 5%

Zinc Oxide 5%

Purpose

Sunscreen

Use

  • helps prevent sunburn

Warnings

For external use only

Do not use on damaged or broken skin

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.

Directions

  • apply after cleanser, toner, and foundation primer. Blend outward with Sei Bella foundation brush or fingers.
  • 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

Other information

  • dermatologist and allergy tested
  • protect this product from excesssive heat and direct sun

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)

Tinted BB Moisturizing Creme
(click image for full-size original)

SEI BELLA TINTED BB MOISTURIZING CREME LIGHT TO MEDIUM 160 N
titanium dioxide 5% and zinc oxide 5% lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-283
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 1.5 g in 30 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.5 g in 30 mL
Inactive Ingredients
Ingredient Name Strength
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
MAGNESIUM ASCORBYL PHOSPHATE (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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54473-283-01 1 BOTTLE, DISPENSING in 1 BOX contains a BOTTLE, DISPENSING (54473-283-30)
1 NDC:54473-283-30 30 mL in 1 BOTTLE, DISPENSING This package is contained within the BOX (54473-283-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 05/01/2018
Labeler — Melaleuca Inc. (139760102)
Registrant — Melaleuca Inc. (139760102)
Establishment
Name Address ID/FEI Operations
Mana 078870292 manufacture (54473-283)

Revised: 05/2018 Melaleuca Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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