Naked Sundays Spf50 Sheer Glow Balm Rose 9g

Naked Sundays Spf50 Sheer Glow Balm Rose 9g
SPL v4
SPL
SPL Set ID fbfbd0dd-8961-5fd0-e053-6294a90a5de4
Route
TOPICAL
Published
Effective Date 2022-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (22.75 g)
Inactive Ingredients
Isostearic Acid Carnauba Wax Ceresin Coco-caprylate/caprate C12-20 Alkyl Benzoate Candelilla Wax Castor Oil Mica Theobroma Grandiflorum Seed Butter Polyglyceryl-3 Pentaricinoleate .alpha.-tocopherol Acetate, D-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-22

Description

ZINC OXIDE 22.75 %

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Dosage and Administration

For External use Only

Description

ZINC OXIDE 22.75 %

Use

- Helps prevents sunburn

- If used as directed with other sun protection measures ( see directions) decreases the risk of skin cancer and early skin ageing caused by the sun.

Label

Section 50565-1

If product is swallowed , get medical help or contact a poison control center right away

Section 50567-7

keep out of eyes, Rinse with water to remove

Section 60561-8

Protect the product in this container from excessive heat & direct sun

Warnings

FOR EXTERNAL USE ONLY

- Do not use on damaged or broken skin.

Skin Cancer/Skin Aging Alert: Spending time in the sun

increases your risk of skin cancer and early skin aging.

To decrease this risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measure including - Limit time in the sun especially from 10:00 AM to 2: 00 PM , Wear Long Slleve Shirts, pants hats and Sunglasses.

Directions

Apply generously 20 minutes before sun exposure.

Use a water-resistant sunscreen if swimming or sweating.

Reapply immediately after towel drying.

Reapply at least every 2 hours.

Children under 6 months of age: Ask a doctor.

Active Ingredients

ZINC OXIDE 22.75 %

Inactive Ingredients

Inactive Ingredients:

C12- C15 Alkyl Benzoate, Candelilla Wax, Carnauba Wax, Castor Oil. Coco Caprylate/Caprate, Dl-alpha-tocopheryl Acetate, Isostearic Acid, Mica, Ozokerite, Polyglyceryl-3 Polyglyceryl-3 Polyricinoleate, Theobroma Cacao ( Cocoa) Seed Butter

Stop Use & Ask Doctor

If rash occurs

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 inclusing:

- limit time in the sun, especially from 10:00 AM- 02:00 PM

- Wear long- Sleeved shirts , pants, Hats and sunglasses


Structured Label Content

Use (USE)

- Helps prevents sunburn

- If used as directed with other sun protection measures ( see directions) decreases the risk of skin cancer and early skin ageing caused by the sun.

Label

Dosage and Administration (34068-7)

For External use Only

Section 50565-1 (50565-1)

If product is swallowed , get medical help or contact a poison control center right away

Section 50567-7 (50567-7)

keep out of eyes, Rinse with water to remove

Section 60561-8 (60561-8)

Protect the product in this container from excessive heat & direct sun

Purpose (PURPOSE)

SUNSCREEN

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

- Do not use on damaged or broken skin.

Skin Cancer/Skin Aging Alert: Spending time in the sun

increases your risk of skin cancer and early skin aging.

To decrease this risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measure including - Limit time in the sun especially from 10:00 AM to 2: 00 PM , Wear Long Slleve Shirts, pants hats and Sunglasses.

Directions

Apply generously 20 minutes before sun exposure.

Use a water-resistant sunscreen if swimming or sweating.

Reapply immediately after towel drying.

Reapply at least every 2 hours.

Children under 6 months of age: Ask a doctor.

Active Ingredients (ACTIVE INGREDIENTS)

ZINC OXIDE 22.75 %

Inactive Ingredients

Inactive Ingredients:

C12- C15 Alkyl Benzoate, Candelilla Wax, Carnauba Wax, Castor Oil. Coco Caprylate/Caprate, Dl-alpha-tocopheryl Acetate, Isostearic Acid, Mica, Ozokerite, Polyglyceryl-3 Polyglyceryl-3 Polyricinoleate, Theobroma Cacao ( Cocoa) Seed Butter

Stop Use & Ask Doctor (Stop use & ask doctor)

If rash occurs

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 inclusing:

- limit time in the sun, especially from 10:00 AM- 02:00 PM

- Wear long- Sleeved shirts , pants, Hats and sunglasses


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)