note bb cream advanced skin corrector spf 15, 500

note bb cream advanced skin corrector spf 15, 500
SPL v1
SPL
SPL Set ID 0a02afa5-da58-4813-aab3-6d541e4fec20
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
water cyclomethicone 5 butylene glycol dimethicone, unspecified hexamethylene diisocyanate/trimethylol hexyllactone crosspolymer mica disteardimonium hectorite aluminum starch octenylsuccinate phenoxyethanol alcohol glycerin .alpha.-tocopherol acetate sodium chloride triethoxycaprylylsilane propylene glycol ethylhexylglycerin silicon dioxide butylated hydroxytoluene bitter orange sorbitol sodium ascorbate sunflower oil tocopherol sodium hydroxide wheat grapefruit

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-01-29

Purpose

Sunscreen

Description

Octinoxate 0.6%


Medication Information

Warnings

For external use only.

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

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

Water (Aqua), Cyclopentasiloxane, PEG-10 Dimethicone, Butylene Glycol, Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Mica, Disteardimonium Hectorite, Aluminum Starch Octenylsuccinate, Phenoxyethanol, Alcohol, Glycerin, Tocopheryl Acetate, Trimethylsiloxysilicate, Bran ( Triticum vulgare) Extract, Dimethicone/Vinyl Dimethicone Crosspolymer, Sodium Chloride, Triethoxycaprylylsilane, Propylene Glycol, Ethylhexylglycerin, Fragrance (Parfum), 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)

Description

Octinoxate 0.6%

Do Not Use
  • on damaged or broken skin
Drug Facts

Active Ingredient

Octinoxate 0.6%

Package Labeling:

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

Warnings

For external use only.

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

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

Water (Aqua), Cyclopentasiloxane, PEG-10 Dimethicone, Butylene Glycol, Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Mica, Disteardimonium Hectorite, Aluminum Starch Octenylsuccinate, Phenoxyethanol, Alcohol, Glycerin, Tocopheryl Acetate, Trimethylsiloxysilicate, Bran ( Triticum vulgare) Extract, Dimethicone/Vinyl Dimethicone Crosspolymer, Sodium Chloride, Triethoxycaprylylsilane, Propylene Glycol, Ethylhexylglycerin, Fragrance (Parfum), 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)

Do Not Use (Do not use)
  • on damaged or broken skin
Drug Facts

Active Ingredient (Active ingredient)

Octinoxate 0.6%

Package Labeling:

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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