SPF50 SHEER GLOW BALM ROSE 9g

Manufacturer
NAKED SUNDAY PTY LTD
Effective date
2025-03-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:58:21

Label at a glance#

ProductSPF50 SHEER GLOW BALM ROSE 9g
Active ingredientZINC OXIDE
Label structure13 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 22.75 %

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USE

INDICATIONS & USAGE SECTION

- 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

WARNINGS SECTION

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 SECTION

keep out of eyes, Rinse with water to remove

Stop use & ask doctor

OTC - STOP USE SECTION

If rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

INSTRUCTIONS FOR USE SECTION

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 :

SUMMARY OF SAFETY AND EFFECTIVENESS

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 INGREDIENT SECTION

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

DOSAGE & ADMINISTRATION SECTION

For External use Only

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81104-898-01SPF50 SHEER GLOW BALM ROSE 9g9 g in 1 PACKAGELIPSTICK94

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81104-898SPF50 SHEER GLOW BALM ROSE 9G (ZINC OXIDE 22.75%) LIPSTICK [NAKED SUNDAY PTY LTD]4Current NDC, 1 package rows20250402_fbfbd0dd-8961-5fd0-e053-6294a90a5de4.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81104-89881104-898-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF50 SHEER GLOW BALM ROSE 9gZINC OXIDE 22.75%NAKED SUNDAY PTY LTDfbfbd0dd-8961-5fd0-e053-6294a90a5de42025-03-22WarningsExact identifier
ndc (package): 81104-898-01
ndc (product): 81104-898
ndc11 (package): 81104089801
spl id: 30f0f6c2-76bf-0442-e063-6294a90a8c61
spl set id: fbfbd0dd-8961-5fd0-e053-6294a90a5de4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.