Belasol Suncream Non-tinted Moisturizing Sunscreen Spf 50

Belasol Suncream Non-tinted Moisturizing Sunscreen Spf 50
SPL v1
SPL
SPL Set ID f22626c1-0996-41d8-a2ec-3bf7491df657
Route
TOPICAL
Published
Effective Date 2024-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ci 77891 (20 mg) Zinc Cation (170 mg)
Inactive Ingredients
Water Butyloctyl Salicylate Green Tea Leaf Caprylic/capric Triglyceride Citric Acid Caprylyl Glycol Cocos Nucifera (coconut) Oil Dodecane Glycerin Glyceryl Laurate Glyceryl Stearate Glyceryl Stearate Citrate Hydrogenated Methyl Abietate Ferrosoferric Oxide Ferric Oxide Red Ferric Oxide Yellow Isododecane Polysilicone-15 Polysorbate 20 Pomegranate Squalane Stearic Acid Ascorbic Acid Ubidecarenone Xanthan Gum Corn

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-25

Description

Titanium Dioxide 2.00% Zinc Oxide 17.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium 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 ), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings:

For external use only

Do Not Use
  • On damaged or broken skin.
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.
  • Immediately 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.
Package Labeling:

Active Ingredients

Titanium 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, Camellia 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.
If Pregnant Or Breast Feeding,

ask a health professional before use.

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.
  • 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 ), decreases the risk of skin cancer and early skin aging caused by the sun.
Purpose

Sunscreen

Warnings:

For external use only

Do Not Use (Do not use)
  • On damaged or broken skin.
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.
  • Immediately 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.
Package Labeling:

Active Ingredients

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

ask a health professional before use.

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.


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