NAKED SUNDAYS MINI SPF HEROS SPF 50- titanium oxide, zinc oxide liquid

NAKED SUNDAYS MINI SPF HEROS by

Drug Labeling and Warnings

NAKED SUNDAYS MINI SPF HEROS 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

Active Ingredients:
Mentioned on individual monocarton

Purpose

Sunscreen

USES

Uses: refer on pack

WARNINGS

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.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• SPRAY 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE.
• Reapply after 80 minutes of swimming or sweating.
• Reapply immediately after towel drying.
• Reapply at least every 2 hours.
• Children under 3 years 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 including:

• Limit time in the sun, especially from 10.00AM - 2.00PM
• Wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENTS

Inactive Ingredients: Aluminum Hydroxide,
Aqua, Butyloctyl Salicylate, C12-15 Alkyl
Benzoate, Coco-Caprylate/Caprate, Dimethicone,
Dunaliella Salina Extract, Ethylhexyl
Methoxycrylene, Ethylhexylglycerin, Hibiscus
sabdariffa Flower Extract, Hydroxyacetophenone,
Iron Oxides, Isododecane, Isostearic Acid, Lauryl
PEG-8 Dimethicone, Magnesium Sulfate, Mica,
Phenoxyethanol, Polyglyceryl-2 Tetraisostearate,
Polyglyceryl-2 Tetraisostearate, Polyglyceryl-3
Polyricinoleate, Propanediol, Sodium Hyaluronate,
Stearic Acid, Silica, Simmondsia Chinensis
(Jojoba) Seed, Tin Oxide.

OTHER INFORMATION

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

USER SAFETY WARNINGS

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 lime 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

Label

INGREDIENTS AND APPEARANCE

NAKED SUNDAYS MINI SPF HEROS  SPF 50
titanium oxide, zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81104-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.3 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
STANNIC OXIDE (UNII: KM7N50LOS6)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOSTEARIC ACID (UNII: X33R8U0062)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-2 TETRAISOSTEARATE (UNII: KN8R167SEQ)
PROPANEDIOL (UNII: 5965N8W85T)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
ISODODECANE (UNII: A8289P68Y2)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8)
MICA (UNII: V8A1AW0880)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
DUNALIELLA SALINA (UNII: F4O1DKI9A6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81104-001-01	40 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	10/06/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/06/2023

Labeler - NAKED SUNDAYS PTY LTD (746918845)