Note Bb Concealer Sunscreen Spf 15, 02

Note Bb Concealer Sunscreen Spf 15, 02
SPL v1
SPL
SPL Set ID d6d6d8d6-08a6-46fa-b808-cfaa29bfbe09
Route
TOPICAL
Published
Effective Date 2024-09-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (6 mg)
Inactive Ingredients
Cyclomethicone 5 Water Butylene Glycol Dimethicone, Unspecified Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer Disteardimonium Hectorite Aluminum Starch Octenylsuccinate Phenoxyethanol Alcohol Triethoxycaprylylsilane Glycerin .alpha.-tocopherol Acetate Sodium Chloride Propylene Glycol Ethylhexylglycerin Silicon Dioxide Butylated Hydroxytoluene Bitter Orange Sorbitol Sodium Ascorbate Sunflower Oil Tocopherol Sodium Hydroxide Grapefruit Wheat

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-29

Description

Octinoxate 0.6%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 0.6%

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
  • 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, 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-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months of age: Ask a doctor
Do Not Use
  • on damaged or broken skin
Drug Facts

Active Ingredient

Octinoxate 0.6%

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

Inactive Ingredients

Cyclopentasiloxane, Water (Aqua), PEG-10 Dimethicone, Butylene Glycol, Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Disteardimonium Hectorite, Aluminum Starch Octenylsuccinate, Phenoxyethanol, Alcohol, Triethoxycaprylylsilane, Glycerin, Tocopheryl Acetate, Trimethylsiloxysilicate, Bran (Triticum vulgare) Extract, Sodium Chloride, Dimethicone/Vinyl Dimethicone Crosspolymer, Propylene Glycol, Ethylhexylglycerin, Silica, BHT, Bitter Orange(Citrus aurantium) Fruit Extract, Grapefruit (Citrus paradisi) Fruit Extract, Lecithin, Sorbitol, Sodium Ascorbate, Sunflower (Helianthus annus) Seed Oil, Tocopherol, Sodium Hydroxide. May contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

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 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
  • 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, 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-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months of age: Ask a doctor
Do Not Use (Do not use)
  • on damaged or broken skin
Drug Facts

Active Ingredient (Active ingredient)

Octinoxate 0.6%

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

Inactive Ingredients (Inactive ingredients)

Cyclopentasiloxane, Water (Aqua), PEG-10 Dimethicone, Butylene Glycol, Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Disteardimonium Hectorite, Aluminum Starch Octenylsuccinate, Phenoxyethanol, Alcohol, Triethoxycaprylylsilane, Glycerin, Tocopheryl Acetate, Trimethylsiloxysilicate, Bran (Triticum vulgare) Extract, Sodium Chloride, Dimethicone/Vinyl Dimethicone Crosspolymer, Propylene Glycol, Ethylhexylglycerin, Silica, BHT, Bitter Orange(Citrus aurantium) Fruit Extract, Grapefruit (Citrus paradisi) Fruit Extract, Lecithin, Sorbitol, Sodium Ascorbate, Sunflower (Helianthus annus) Seed Oil, Tocopherol, Sodium Hydroxide. May contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

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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