NAKED SUNDAYS GLOW BALM MINERAL PEPTIDE STICK BROAD SPECTRUM SPF50 BRONZE 8G- zinc oxide stick

Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Bronze 8g by

Drug Labeling and Warnings

Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Bronze 8g by is a Otc medication manufactured, distributed, or labeled by NAKED SUNDAYS PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide 22.1 %

uses

SPF Product

DOSAGE & ADMINISTRATION

Directions: Shake well before use.
Apply liberally and reapply every 80 minutes,
especially after swimming or towel drying.
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 including: Limit time in the sun,
especially from 10 am-2 pm Wear longsleeved
shirts, pants, hats, and sunglasses For
Children under 6 months of age ask a doctor.

Warning

Warnings: For external use only. Do not use
on damaged or broken skin Avoid prolonged
sun exposure. If it gets in your eyes, wash well
with water. Keep out of reach of children.
Stop use and ask a doctor if rashes occur.
If product is swallowed, get medical help or
contact a Poison Control Center right away.

INACTIVE INGREDIENTS

INACTIVE INGREDIENTS: Bis-Diglyceryl Polyacyladipate-2, Butylene Glycol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Coco-Caprylate/Caprate, Cocos Nucifera (Coconut) Oil, Dextrin Palmitate, Diisostearyl Malate, Ethylhexyl Methoxycrylene, Ethylhexyl Palmitate, Euphorbia Cerifera (Candelilla) Wax, Hexylene Glycol, Iron Oxides, Isostearic acid, Mica, Ozokerite, Palmitoyl Hexapeptide‐12, Pentaerythrityl Tetraisostearate, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Phenyl Trimethicone, Polyglyceryl-3 Polyricinoleate, Propylene Carbonate, Silica, Silica Dimethyl Silylate, Sodium Hyaluronate, Stearalkonium Hectorite

Other Information:

Other Information: Protect this product
from excess heat and direct sun. Store below
30°C / 86°F.

QUESTIONS

Questions: info@nakedsundays.com

INDICATIONS & USAGE

Uses: Helps prevent 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.

KEEP OUT OF REACH OF CHILDREN

Warnings: For external use only. Do not use
on damaged or broken skin Avoid prolonged
sun exposure. If it gets in your eyes, wash well
with water. Keep out of reach of children.
Stop use and ask a doctor if rashes occur.
If product is swallowed, get medical help or
contact a Poison Control Center right away.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NAKED SUNDAYS GLOW BALM MINERAL PEPTIDE STICK BROAD SPECTRUM SPF50 BRONZE 8G 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81104-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
ISOSTEARIC ACID (UNII: X33R8U0062)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
IRON OXIDES (UNII: 1K09F3G675)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PERSEA GRATISSIMA (AVOCADO) OIL (UNII: 6VNO72PFC1)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
MICA (UNII: V8A1AW0880)
SILICA (UNII: ETJ7Z6XBU4)
EUPHORBIA CERIFERA (CANDELILLA) WAX (UNII: WL0328HX19)
CERESIN (UNII: Q1LS2UJO3A)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81104-104-01	8 g in 1 PACKAGE; Type 0: Not a Combination Product	03/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/01/2025

Labeler - NAKED SUNDAYS PTY LTD (746918845)