Belasol Sun Cream Non-tinted Moisturizing Spf 50

Belasol Sun Cream Non-tinted Moisturizing Spf 50
SPL v1
SPL
SPL Set ID fb677ad0-2791-44ec-9720-951471ec009a
Route
TOPICAL
Published
Effective Date 2023-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (20 mg) Zinc Cation (170 mg)
Inactive Ingredients
Water Butyloctyl Salicylate Green Tea Leaf Medium-chain Triglycerides Citric Acid Monohydrate Caprylyl Glycol Coconut Oil Dodecane Glycerin Glyceryl Laurate Glyceryl Monostearate Glyceryl Stearate Citrate Glyceryl 1-undecylenate Hydrogenated Methyl Abietate Ferric Oxide Red Isododecane Polyhydroxystearic Acid (2300 Mw) Polysilicone-15 Polysorbate 20 Punica Granatum Root Bark Squalane Stearic Acid Tetrahexyldecyl Ascorbate Trimethylsiloxysilicate (m/q 0.6-0.8) Ubidecarenone Xanthan Gum Corn

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-20

Description

Titanuium Dioxide 2.00% Zinc Oxide 17.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanuium Dioxide 2.00% Zinc Oxide 17.00%

Uses:
  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • Retains SPF after 40 minutes of swimming or sweating.
  • If used as directed with other sun protection measures (see Directions ), decrease the risk of skin cancer and early skin aging caused by the sun.
Warnings:

For external use only

Drug Facts

Questions?

(786) 361-7266

Directions:
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply:
  • After 40 minutes of swimming or sweating.
  • Imediately after towel drying.
  • At least every 2 hours.
  • 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, especially from 10 a.m - 2 p.m.
  • Wear long sleeved shirts, pants, hats, and sunglasses.
Do Not Use 
  • On damaged or broken skin.
Package Labeling:

Active Ingredients

Titanuium Dioxide 2.00%

Zinc Oxide 17.00%

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

Aqua (Deionized Water), Butyloctyl salicylate, Camelllia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citric Acid, Caprylyl Glycol, Cocos Nucifera (Coconut) Oil, Dodecane, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Hydrogenated Methyl Abietate, Iron Oxides (Black, Red, Yellow), Isododecane, Polyhydroxystearic Acid, Polysilicone-15, Polysorbate-20, Punica Granatum (Pomegranate) Extract, Squalane, Stearic Acid, Tetrahexyldecyl Ascorbate (Vitamin C), Trimethylsiloxysilicate, Ubiquinone (CoQ10), Xanthan Gum, Zemea (Corn) Propanediol.

When Using This Product
  • Keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If
  • Rash or irritation develops and lasts.
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.


Structured Label Content

Uses:
  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • Retains SPF after 40 minutes of swimming or sweating.
  • If used as directed with other sun protection measures (see Directions ), decrease the risk of skin cancer and early skin aging caused by the sun.
Purpose

Sunscreen

Warnings:

For external use only

Drug Facts

Questions?

(786) 361-7266

Directions:
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply:
  • After 40 minutes of swimming or sweating.
  • Imediately after towel drying.
  • At least every 2 hours.
  • 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, especially from 10 a.m - 2 p.m.
  • Wear long sleeved shirts, pants, hats, and sunglasses.
Do Not Use  (Do not use )
  • On damaged or broken skin.
Package Labeling:

Active Ingredients

Titanuium Dioxide 2.00%

Zinc Oxide 17.00%

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

Aqua (Deionized Water), Butyloctyl salicylate, Camelllia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citric Acid, Caprylyl Glycol, Cocos Nucifera (Coconut) Oil, Dodecane, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Hydrogenated Methyl Abietate, Iron Oxides (Black, Red, Yellow), Isododecane, Polyhydroxystearic Acid, Polysilicone-15, Polysorbate-20, Punica Granatum (Pomegranate) Extract, Squalane, Stearic Acid, Tetrahexyldecyl Ascorbate (Vitamin C), Trimethylsiloxysilicate, Ubiquinone (CoQ10), Xanthan Gum, Zemea (Corn) Propanediol.

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 or irritation develops and lasts.
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,  (If pregnant or breast-feeding, )

ask a health professional before use.


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Raw Label Data

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