NAKED SUNDAYS SPF50 SHEER GLOW BALM TRIO 3 x 9g

SPF50 SHEER GLOW BALM TRIO by

Drug Labeling and Warnings

SPF50 SHEER GLOW BALM TRIO by is a Otc medication manufactured, distributed, or labeled by NAKED SUNDAY PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPF50 SHEER GLOW BALM TRIO- zinc oxide 22.75% lipstick 
NAKED SUNDAY PTY LTD

----------

NAKED SUNDAYS SPF50 SHEER GLOW BALM TRIO 3 x 9g

ACTIVE INGREDIENTS

ZINC OXIDE 22.75 %

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.

keep out of eyes, Rinse with water to remove

Stop use & ask doctor

If rash occurs

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

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

For External use only

Label

1234

SPF50 SHEER GLOW BALM TRIO 
zinc oxide 22.75% lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 81104-899
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE22.75 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
CERESIN (UNII: Q1LS2UJO3A)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)  
CANDELILLA WAX (UNII: WL0328HX19)  
CASTOR OIL (UNII: D5340Y2I9G)  
MICA (UNII: V8A1AW0880)  
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 81104-899-0110 g in 1 KIT; Type 0: Not a Combination Product12/26/202207/18/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/26/202207/18/2025
Labeler - NAKED SUNDAY PTY LTD (746918845)

Revised: 7/2025
 

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.