Otc - Active Ingredient
Active ingredient
Zinc Oxide - 23,5% ........ Sunscreen
Broad Spectrum Spf 50 Sunscreen Lotion
FDA Label NDC 87693-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Skin Damage Inc. for the product Broad Spectrum Spf 50 Sunscreen (NDC 87693-001). 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
Helps prevent sunburn
Warnings
Warnings
For external use only
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
Stop use and ask a dector if rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed,
get medical help or contact a Poison Control
Center right away
Dosage & Administration
Directions
Apply liberally 15 minutes before sun
exposure Reapply after 80 minutes
of swimming or sweating immediately
after towel drying at least every 2 hours
Chiidren under 6 months: 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:
Imit time in the sun, especially from
10 a.m .- 2 p.m.
wear long-sleeved shirts, pants, hats
and sunglasses
Inactive Ingredient
Inactive ingredients
Neopentyl Glycol Diethylhexancate, Cera
Alba (Beeswax), Euphorbia Cerifera
(Candellla) Wax, Caprylic/Capric Triglyceride,
Hydrogenated Castor Oil/Sebacic Acid
Copolymer, Triheptanoin, Polyhydroxystearic
Acid, VP/Eicosene Copolymer, Argania
Spinosa Kermel Oil, Helianthus Annuus
(Sunflower) Seed Oil, C13-16 Isoalkane
Neopentyl Glycol Diisostearate, Butyrospermum
Parkii (Shea) Butter, Castor Isostearate
Succinate, Octyldodecanol, Octyldodecyl
Dilinoleyl
Alcohol/Succinic
Acid Copolymer, Ethyl Ferulate, Slica
Dimethyl Silylate, Coco-Caprylate/Caprate,
Triethoxycaprylsilane, C9-12 Akane
Polyurethane-100, Iron Oxides
Storage And Handling
Protect the product in this container from
excessive heat and direct sun.
Package Label.Principal Display Panel
Labeling (Artwork)
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