SPF50 SHEER GLOW BALM ROSE 9G- zinc oxide 22.75% lipstick

SPF50 SHEER GLOW BALM ROSE 9g by

Drug Labeling and Warnings

SPF50 SHEER GLOW BALM ROSE 9g by is a Otc medication manufactured, distributed, or labeled by NAKED SUNDAY PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

WHEN USING

keep out of eyes, Rinse with water to remove

Stop use & ask doctor

If rash occurs

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

DOSAGE & ADMINISTRATION

For External use Only

Label

INGREDIENTS AND APPEARANCE

SPF50 SHEER GLOW BALM ROSE 9G 
zinc oxide 22.75% lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81104-898
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22.75 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARIC ACID (UNII: X33R8U0062)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81104-898-01	9 g in 1 PACKAGE; Type 0: Not a Combination Product	12/26/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/22/2022

Labeler - NAKED SUNDAY PTY LTD (746918845)