NAKED SUNDAYS COLLAGEN GLOW 100% MINERAL SUNSCREEN SPF 50- zinc oxide liquid

NAKED SUNDAYS COLLAGEN GLOW 100% MINERAL SUNSCREEN by

Drug Labeling and Warnings

NAKED SUNDAYS COLLAGEN GLOW 100% MINERAL 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.
Skin Cancer/Skin Aging Alert: Spending time in the
sun increases your risk of skin cancer and early skin
aging. This product has been shown only to help
prevent sunburn, not skin cancer or early skin aging
Do not use on damaged or broken skin. Do not use
on damaged or broken skin.
When using this product: Keep out of eyes. Rinse
with water to remove.
Stop use and ask a 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.

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:
Aqua, Coco-Caprylate/Caprate, Octyldodecanol,
Caprylic/Capric Triglyceride, PEG-30
Dipolyhydroxystearate, Glycerin, Cetearyl alcohol,
Polyglyceryl-3 Polyricinoleate, Citrullus Lanatus
(Watermelon) Seed Oil, Disodium EDTA, Sodium
chloride, Xanthan Gum, Gluconolactone, Isostearic
acid, Cetearyl glucoside, Sodium benzoate,
Hydrolyzed Soy Protein, Rice amino acids, Calcium
Gluconate, Proline, Hydrolyzed Adansonia Digitata
Seed Extract, Iron Oxides.

OTHER INFORMATION

Other Information:
Protect the product in this container from excessive
heat and direct sun.

USER SAFETY WARNINGS

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 to 2PM
Wear long-sleeved shirts, pants, hats, and sunglasses

directions

Directions:
Apply generously 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 6 months of age: Ask a doctor.

Label

INGREDIENTS AND APPEARANCE

NAKED SUNDAYS COLLAGEN GLOW 100% MINERAL SUNSCREEN  SPF 50
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81104-002
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 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
PROLINE (UNII: 9DLQ4CIU6V)
OCTYLDODECANOL (UNII: 461N1O614Y)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
WATERMELON SEED OIL (UNII: L33J06UQTT)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOSTEARIC ACID (UNII: X33R8U0062)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ADANSONIA DIGITATA SEED (UNII: 2936P60TPX)
FERRIC OXIDE RED (UNII: 1K09F3G675)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
AMINO ACIDS, RICE (UNII: 5ET1T25H82)
CALCIUM GLUCONATE (UNII: SQE6VB453K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81104-002-01	50 mL in 1 BOTTLE; 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)