Otc - Active Ingredient
Active Ingredients
Avobenzone 3 %
Homosolate 10%
octisalate 5 %
Octocrylene 10%
Naked Sundays Golden Glow Body Sunscreen Spf50 100ml Cream
FDA Label NDC 81104-500
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Naked Sundays Pty Ltd for the product Naked Sundays Golden Glow Body Sunscreen Spf50 100ml (NDC 81104-500). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product: Keep out of eyes. Rinse with
water to remove
Otc - Stop Use
if rashes occur
Otc - 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
Other Information:
Protect the product in this container from excessive heat and
direct sun.
Inactive Ingredient
Camellia Sinensis Leaf Extract, Carbomer,
Cetearyl alcohol, Cetearyl glucoside, Dimethicone,
Gluconolactone, Mica, Octyldodecanol, Potassium cetyl
phosphate, Purified water, Sodium Benzoate, Trolamine.
Description
THIS MULTI TASKING BODY SHIMMER,
MOISTURISER, AND SPF IN ONE
WILL LEAVE YOUR LIMBS GLOSSY, GOLDEN
AND SUMMER READY!
* Please review the disclaimer below.
