Spit & Polish Sun Smart Sunscreen Lotion Spf 50

Spit & Polish Sun Smart Sunscreen Lotion Spf 50
SPL v2
SPL
SPL Set ID af879a05-1483-5c11-e053-2995a90af45d
Route
TOPICAL
Published
Effective Date 2020-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (70 mg) Zinc Cation (100 mg)
Inactive Ingredients
Aloe Vera Leaf Butyloctyl Salicylate Glyceryl Tristearate Medium-chain Triglycerides Stearalkonium Hectorite Propylene Carbonate White Wax Carrot Glycerin Green Tea Leaf Hydrogenated Coco-glycerides Glycyrrhiza Glabra Leuconostoc/radish Root Ferment Filtrate Magnesium Sulfate, Unspecified Form Sorbitan Monooleate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-01

Description

Titanium Dioxide 7% and Zinc Oxide 10%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 7% and Zinc Oxide 10%

Uses:

Helps prevent sunburn. If used as directed with other sun protection measures decreases the risk of skin cancer and early aging caused by the sun.

Warning:

For external use only.

Drug Facts

Do Not Use

on damaged or broken skin.

Directions:

Apply liberally and evenly 15 minutes prior to sun exposure. Reapply after 80 minutes of swimming or sweating Reapply after towel drying. Reapply at least every 2 hours.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including limiting time in the sun. especially between 10 a.m. and 2 pm, and wear long-sleeved shirts, pants, hats and sunglasses. Sun protection measures:

: Consult a physician. For use on children under 6

Package Labeling:

Active Ingredients

Titanium Dioxide 7% and Zinc Oxide 10%

Other Information:

Protect this product from excessive heat or direct sun.

Inactive Ingredients:

ALOE BARBADENSIS LEAF GEL,BUTYLOCTYL SALICYLATE, CAPRYLIC/ CAPRIC/ MYRISTIC/STEARIC TRIGLYCERIDES, CAPRYLIC/CAPRIC/TRIGLYCERIDE (AND) STEARALKONIUM HECTORITE (AND) PROPYLENE CARBONATE, CERA ALBA, DAUCUS CAROTA SATIVA (CARROT) EXTRACT, GLYCERIN (AND) CAMELLIA SINENSIS LEAF EXTRACT, HYDROGENATED COCO-GLYCERIDES, GLYCRRHIZA GLABRA (LICORICE) ROOT EXTRACT, LEUCONO STOC/RADISH ROOT FERMENT FILTRATE, MAGNESIUM SULFATE. POLYGLYCERYL 3 POLYRICINOLEATE, POLY- HYDROXYSTEARIC ACID, SORBITAN OLEATE, WATER.

When Using This Product

avoid contact with eyes, contact with eyes occurs, flush with water to remove.

Stop Use and Ask A Doctor

If irritation or rash develops or persists.

Keep Out of Reach of Children.

If swallowed, seek immediate medical attention of contact a Poison Control Center right away.


Structured Label Content

Uses:

Helps prevent sunburn. If used as directed with other sun protection measures decreases the risk of skin cancer and early aging caused by the sun.

Purpose

Sunscreen

Warning:

For external use only.

Drug Facts (DRUG FACTS)

Do Not Use (Do not use)

on damaged or broken skin.

Directions:

Apply liberally and evenly 15 minutes prior to sun exposure. Reapply after 80 minutes of swimming or sweating Reapply after towel drying. Reapply at least every 2 hours.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including limiting time in the sun. especially between 10 a.m. and 2 pm, and wear long-sleeved shirts, pants, hats and sunglasses. Sun protection measures:

: Consult a physician. For use on children under 6

Package Labeling:

Active Ingredients

Titanium Dioxide 7% and Zinc Oxide 10%

Other Information: (Other information:)

Protect this product from excessive heat or direct sun.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

ALOE BARBADENSIS LEAF GEL,BUTYLOCTYL SALICYLATE, CAPRYLIC/ CAPRIC/ MYRISTIC/STEARIC TRIGLYCERIDES, CAPRYLIC/CAPRIC/TRIGLYCERIDE (AND) STEARALKONIUM HECTORITE (AND) PROPYLENE CARBONATE, CERA ALBA, DAUCUS CAROTA SATIVA (CARROT) EXTRACT, GLYCERIN (AND) CAMELLIA SINENSIS LEAF EXTRACT, HYDROGENATED COCO-GLYCERIDES, GLYCRRHIZA GLABRA (LICORICE) ROOT EXTRACT, LEUCONO STOC/RADISH ROOT FERMENT FILTRATE, MAGNESIUM SULFATE. POLYGLYCERYL 3 POLYRICINOLEATE, POLY- HYDROXYSTEARIC ACID, SORBITAN OLEATE, WATER.

When Using This Product (When using this product)

avoid contact with eyes, contact with eyes occurs, flush with water to remove.

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

If irritation or rash develops or persists.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, seek immediate medical attention of contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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