Unisex Bb Tint- It's Clear - 6553

Unisex Bb Tint- It's Clear - 6553
SPL v1
SPL
SPL Set ID 9cc1d1c0-fa52-4883-9dc4-95fb5292eaa4
Route
TOPICAL
Published
Effective Date 2021-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (74.7 mg)
Inactive Ingredients
Water Coco-caprylate Dicaprylyl Carbonate Shea Butter Ethyl Esters C15-19 Alkane Glycerin Magnesium Stearate Polyglyceryl-6 Polyricinoleate Silicon Dioxide Avocado Oil Sodium Chloride Magnesium Sulfate, Unspecified Form Hyaluronate Sodium Asian Ginseng Centella Asiatica Triterpenoids Tocopherol Phenoxyethanol Ethylhexylglycerin Sodium Benzoate Potassium Sorbate Citric Acid Monohydrate Ferric Oxide Red Ferrosoferric Oxide Ferric Oxide Yellow

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-01-11

Description

Titanium Dioxide, 7.47%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide, 7.47%

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 15 minutes before sun exposure
  • Children undre 6 months of age: Ask a doctor
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Sun protection measures.
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, reguarly 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 damage or broken skin

Drug Facts

Other Information
  • protect the product in this container from excessive heat and direct sun
Package Labeling:

Active Ingredients

Titanium Dioxide, 7.47%

Inactive Ingredients

Aqua/Water, Coco-Caprylate*, Dicaprylyl Carbonate*, Shea Butter Ethyl Ester*, C15-19 Alkane*, Glycerin*, Magnesium Stearate*, Polyglyceryl-6 Polyhydroxystearate*, Polyglyceryl-6 Polyricinoleate*, Silica*, Jojoba Esters*, Persea Gratissima (Avocado) Oil*, Hydrogenated Vegetable Oil*, Sodium Chloride*, Glyceryl Behenate*, Magnesium Sulfate*, Sodium Hyaluronate*, Panax Ginseng Root Extract**, CentellaAsiatica Extract**, Tocopherol*, Polyhydroxystearic Acid*, Phenoxyethanol, Ethylhexylglycerin, Sodium Benzoate, Potassium Sorbate, Parfum/Fragrance, Citric Acid, Iron Oxides Red*, Iron Oxides Black, Iron Oxides Yellow*.

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 15 minutes before sun exposure
  • Children undre 6 months of age: Ask a doctor
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Sun protection measures.
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, reguarly 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 damage 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)

Titanium Dioxide, 7.47%

Inactive Ingredients (Inactive ingredients)

Aqua/Water, Coco-Caprylate*, Dicaprylyl Carbonate*, Shea Butter Ethyl Ester*, C15-19 Alkane*, Glycerin*, Magnesium Stearate*, Polyglyceryl-6 Polyhydroxystearate*, Polyglyceryl-6 Polyricinoleate*, Silica*, Jojoba Esters*, Persea Gratissima (Avocado) Oil*, Hydrogenated Vegetable Oil*, Sodium Chloride*, Glyceryl Behenate*, Magnesium Sulfate*, Sodium Hyaluronate*, Panax Ginseng Root Extract**, CentellaAsiatica Extract**, Tocopherol*, Polyhydroxystearic Acid*, Phenoxyethanol, Ethylhexylglycerin, Sodium Benzoate, Potassium Sorbate, Parfum/Fragrance, Citric Acid, Iron Oxides Red*, Iron Oxides Black, Iron Oxides Yellow*.

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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