Otc - Active Ingredient
Active Ingredients
Zinc Oxide 10.5%
Homosalate 10%
Silk Spf Facial Sunscreen Fluid Hybrid Broad Spectrum Spf 30 Uva/uvb Cream
FDA Label NDC 79356-202
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Onekind.25 for the product Silk Spf Facial Sunscreen Fluid Hybrid Broad Spectrum Spf 30 Uva/uvb (NDC 79356-202). 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
Purpose
Sunscreen
Indications & Usage
Uses
Helps prevent sunburn. If used as
directed with other sun protection
measures (see Directions), decreases
the risk of skin cancer and early skin
aging caused by the sun.
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 doctor 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 generously 15 minutes before sun
exposure. Reapply at least every 2 hours.
Use a water-resistant sunscreen if
swimming or sweating.
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 a.m.- 2
p.m. Wear long-sleeved shirts, pants,
hats, and sunglasses. Children under 6
months of age: ask a doctor.
Inactive Ingredient
Inactive Ingredients
water/aqua/eau, caprylic/capric
triglyceride, glyceryl stearate se, coconut
alkanes, glycerin, coco-caprylate/caprate,
decyl glucoside, oryza sativa (rice) starch,
musa sapientum (banana) flower extract,
polyhydroxystearic acid, polyglyceryl-3
polyricinoleate, isostearic acid, lecithin,
xanthan gum, hydroxyethylcellulose,
caprylyl glycol, caprylhydroxamic acid,
sodium benzoate, citric acid, disodium
phosphate, sodium phosphate.
Package Label.Principal Display Panel
Codsilkspf30 (Codsilkspf30)
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