Bb O'skin Broad Spectrum Spf-30

Bb O'skin Broad Spectrum Spf-30
SPL v2
SPL
SPL Set ID d84cca38-b673-484e-aa25-df58d904d4d3
Route
TOPICAL
Published
Effective Date 2023-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (70 mg) Octocrylene (50 mg) Zinc Cation (60 mg)
Inactive Ingredients
Adansonia Digitata Seed Oil Aloe Vera Leaf Water Shea Butter Alkyl (c12-15) Benzoate Caffeine Calendula Officinalis Flower Green Tea Leaf Medium-chain Triglycerides Caprylyl Glycol Citric Acid Monohydrate Coconut Oil East Indian Lemongrass Oil Decyl Glucoside Dodecane Glycerin Glyceryl Laurate Glyceryl Monostearate Glyceryl Stearate Citrate Helianthus Annuus Flowering Top Hyaluronic Acid Ferric Oxide Red Magnesium Aluminum Silicate Niacinamide Octyldodecyl Neopentanoate Basil Sorbitan Monostearate Ubidecarenone .alpha.-tocopherol Acetate Corn Ginger

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-27

Description

Titanium dioxide 7.00% Octocrylene 5.00% Zinc Oxide 6.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 7.00% Octocrylene 5.00% Zinc Oxide 6.00%

Uses:
  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • if used as directed with other sun protection meassures (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 and as needed.
  • Children under 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 the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, expecially from 10 a.m.-2 p.m.
  • Wear long-sleevd shirts, pants, hats, and sunglasses.
Do Not Use 
  • on damaged or broken skin.
Active Ingredients

Titanium dioxide 7.00%

Octocrylene 5.00%

Zinc Oxide 6.00%

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
Package Labeling:5ml

Inactive Ingredients:

Adansonia Digitata (Baobab) Oil, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea Butter), C12-15 Alkyl Benzoate, Caffeine, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Citric Acid, Cocos Nucifera (Coconut) Oil, Coffea Arabica Seed Extract, Cymbopogon Flexuosus (Lemongrass) Oil, Decyl Glucoside, Dodecane, Glycerin, Glyceryl laurate, Glyceryl Stearate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower Oil), Hyaluronic Acid, Iron Oxides (Black, Red, White, Yellow), Lecithin, Magnesium Aluminum Silicate, Mauritia Flexuosa (Buriti) Oil, Niacinamide, Octyldodecyl Neopentanoate, Ocimum Basilicum (Basil) Extract, Sodium Polyacrylate, Sorbitan Stearate, Ubiquinone (CoQ10), Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol, Zingiber Officinalis (Ginger) Extract, ZIngiber Officinalis (Ginger) Oil,

Questions Or Comments?

(347-335-5540) Visit us: www.oskinstudionyc.com

Package Labeling:50.2ml

When Using This Product
  • keep out of eyes. Rinse with water to remove
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.

Stop Use and Ask A Doctor If 

rash or irritation develops and lasts.

If Pregnant Or Breast Feeding, 

ask a health professional before use.


Structured Label Content

Uses:
  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • if used as directed with other sun protection meassures (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 and as needed.
  • Children under 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 the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, expecially from 10 a.m.-2 p.m.
  • Wear long-sleevd shirts, pants, hats, and sunglasses.
Do Not Use  (Do not use )
  • on damaged or broken skin.
Active Ingredients

Titanium dioxide 7.00%

Octocrylene 5.00%

Zinc Oxide 6.00%

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
Package Labeling:5ml

Inactive Ingredients:

Adansonia Digitata (Baobab) Oil, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea Butter), C12-15 Alkyl Benzoate, Caffeine, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Citric Acid, Cocos Nucifera (Coconut) Oil, Coffea Arabica Seed Extract, Cymbopogon Flexuosus (Lemongrass) Oil, Decyl Glucoside, Dodecane, Glycerin, Glyceryl laurate, Glyceryl Stearate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower Oil), Hyaluronic Acid, Iron Oxides (Black, Red, White, Yellow), Lecithin, Magnesium Aluminum Silicate, Mauritia Flexuosa (Buriti) Oil, Niacinamide, Octyldodecyl Neopentanoate, Ocimum Basilicum (Basil) Extract, Sodium Polyacrylate, Sorbitan Stearate, Ubiquinone (CoQ10), Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol, Zingiber Officinalis (Ginger) Extract, ZIngiber Officinalis (Ginger) Oil,

Questions Or Comments? (Questions or comments?)

(347-335-5540) Visit us: www.oskinstudionyc.com

Package Labeling:50.2ml

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove
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. If pregnant or breast-feeding, ask a health professional before use.

Stop Use and Ask A Doctor If  (Stop use and ask a doctor if )

rash or irritation develops and lasts.

If Pregnant Or Breast Feeding,  (If pregnant or breast-feeding, )

ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

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