Active Ingredients
ZINC OXIDE 22.75 %
Spf50 Sheer Glow Balm Champagne 9g Lipstick
FDA Label NDC 81104-896
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Naked Sunday Pty Ltd for the product Spf50 Sheer Glow Balm Champagne 9g (NDC 81104-896). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, use, warnings, otc - when using, stop use & ask doctor, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
SUNSCREEN
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.
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.
Otc - When Using
keep out of eyes, Rinse with water to remove
Stop Use & Ask Doctor
If rash occurs
Otc - Keep Out Of Reach Of Children
If product is swallowed , get medical help or contact a poison control center right away
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.
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
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
Other Safety Information
Protect the product in this container from excessive heat & direct sun
* Please review the disclaimer below.
