NAKED SUNDAYS BROAD SPECTRUM SUNSCREEN SPF 50- zinc oxide cream

NAKED SUNDAYS BROAD SPECTRUM SUNSCREEN by

Drug Labeling and Warnings

NAKED SUNDAYS BROAD SPECTRUM SUNSCREEN 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:
Zinc Oxide 22.75 %

Purpose

Sunscreen

USES

Use:
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.

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: Ricinus Communis
(Castor) Seed Oil, C12-15 Alkyl Benzoate,
Coco-Caprylate/Caprate, Euphorbia Cerifera
(Candelilla) Wax, Copernicia Cerifera (Carnauba)
Wax, Ceresin, Theobroma Cacao (Cocoa) Seed
Butter, Polyglyceryl-3 Polyricinoleate, Isostearic
Acid, Tocopheryl Acetate, Persea Gratissima
(Avocado) Oil, Iron Oxides (CI 77492, CI 77491)

OTHER INFORMATION

Questions: info@nakedsundays.com

USER SAFETY WARNINGS

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

directions

Directions: Apply generously 20 minutes before
sun exposure. Reapply after 90 minutes, especially
after swimming, exercising or towel drying. Reapply
at least every 2 hours.
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 10AM - 2PM
Wear long-sleeved shirts, pants, hats, and
sunglasses Children under 6 months of age: Ask a
doctor.

Label

INGREDIENTS AND APPEARANCE

NAKED SUNDAYS BROAD SPECTRUM SUNSCREEN  SPF 50
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81104-003
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
THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)
ISOSTEARIC ACID (UNII: X33R8U0062)
AVOCADO OIL (UNII: 6VNO72PFC1)
FERRIC OXIDE RED (UNII: 1K09F3G675)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
CERESIN (UNII: Q1LS2UJO3A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81104-003-01	19 g in 1 TUBE; Type 0: Not a Combination Product	10/10/2023

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)