Scarscreen
FDA Label NDC 70089-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Natural Crest Laboratories Inc. for the product Scarscreen (NDC 70089-100). 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 drug facts, active ingredient, purpose, otc - keep out of reach of children, uses, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Zinc Oxide 15%
Purpose
Sunscreen
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Uses
Helps prevent sunburn.
Warnings
When Using This Product
- If product gets into eyes, rinse thoroughly with water
- If irritation or stinging occurs, wash area with water
For external use only.
If swallowed, get medical help right away.
Do not use on damaged or broken skin.
Stop use and ask doctor if rash occurs.
Directions
Shake Well
| Adults and children 6 months of age and over | Apply liberally and evenly to skin area 15 minutes before you are exposed to sun or water. Reapply at least every two hours. Use a water-resistant sunscreen if swimming or sweating.” |
| Children under 6 months of age | Ask a doctor |
Consult a physician for use on children under 6 months.
Inactive Ingredients
C12-C15 alkyl benzoic acid, Cetearyl alcohol and ceteareth-20, Citric acid, Corn starch, Dimethicone, Ethylhexyl glycerin, Glyceryl stearate, Isostearic acid, Methyl gluceth-10, Methylcellulose, PEG-40 stearate, Polyhydroxystearic acid, Phenoxyethanol, Propylene glycol, SDA 40B alcohol, Xanthan gum, Water
Other
SPF 30
broad spectrum sunscreen
formulated for scars
perfect protection for scars' sensitive skin
UVA/UVB protection
A Sunscreen Especially for Scars. From the Scar Experts at Dermaflage.
Scar tissue is fragile and particularly susceptible to the harmful rays of the sun. That's why we developed ScarScreen, the perfect protection for scars' sensitive skin. Ideal for use following cosmetic procedures, Doctors recommend sun protection for minimizing a scar and preventing hyperpigmentation. Conceal and protect your scar-ScarScreen is specially formulated to work with Dermaflage Topical Filler.
* No synthetic chemical sunscreen
* Hypoallergenic
* Ideal for use after surgery
* Fragrance free
* Specially formulated to work with Dermaflage Topical Filler
Made in the U.S.A.
Distributed by
Silicone Arts Labs, Inc.
Memphis, Tn 38104
Dermaflage.com | 1-855-228-4022
Packaging
Hs1 (Screen1)
* Please review the disclaimer below.
