NAKED SUNDAYS GOLDEN GLOW BODY SUNSCREEN SPF50 100ML cream

Naked Sundays Golden Glow Body Sunscreen SPF50 100ml by

Drug Labeling and Warnings

Naked Sundays Golden Glow Body Sunscreen SPF50 100ml by is a Otc medication manufactured, distributed, or labeled by NAKED SUNDAYS PTY LTD, WILD CHILD W A PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Avobenzone 3 %

Homosolate 10%

octisalate 5 %

Octocrylene 10%

PURPOSE

Sunscreen

INDICATIONS & USAGE

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

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

Do not use on damaged or broken skin

WHEN USING

When using this product: Keep out of eyes. Rinse with
water to remove

STOP USE

if rashes occur

KEEP OUT OF REACH OF CHILDREN

If product is swallowed,
get medical help or cont act a Poison Control Center right
away

DOSAGE & ADMINISTRATION

Directions:
Apply generously 15 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

OTHER SAFETY INFORMATION

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 INGREDIENT

Camellia Sinensis Leaf Extract, Carbomer,
Cetearyl alcohol, Cetearyl glucoside, Dimethicone,
Gluconolactone, Mica, Octyldodecanol, Potassium cetyl
phosphate, Purified water, Sodium Benzoate, Trolamine.

OTHER SAFETY INFORMATION

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

DESCRIPTION

THIS MULTI TASKING BODY SHIMMER,
MOISTURISER, AND SPF IN ONE
WILL LEAVE YOUR LIMBS GLOSSY, GOLDEN
AND SUMMER READY!

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NAKED SUNDAYS GOLDEN GLOW BODY SUNSCREEN SPF50 100ML 
naked sundays golden glow body sunscreen spf50 100ml cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81104-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
TROLAMINE (UNII: 9O3K93S3TK)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)
CARBOMER 940 (UNII: 4Q93RCW27E)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
WATER (UNII: 059QF0KO0R)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81104-500-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/01/2022

Labeler - NAKED SUNDAYS PTY LTD (746918845)

Establishment
Name	Address	ID/FEI	Business Operations
WILD CHILD W A PTY LTD		744660692	manufacture(81104-500)