SCARSCREEN- zinc oxide lotion 
Natural Crest Laboratories Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ScarScreen

Drug Facts

Active Ingredient

Zinc Oxide 15%

Purpose

Sunscreen

Keep out of reach of children.

Uses


Helps prevent sunburn.

Warnings

When Using This Product

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 ageAsk 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

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

SCARSCREEN 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70089-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.75 g  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
STARCH, CORN (UNII: O8232NY3SJ)  
DIMETHICONE 200 (UNII: RGS4T2AS00)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
METHYL GLUCETH-10 (UNII: N0MWT4C7WH)  
METHYLCELLULOSE (4000 MPA.S) (UNII: MRJ667KA5E)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALCOHOL (UNII: 3K9958V90M)  
XANTHAN GUM (UNII: TTV12P4NEE)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70089-100-111 in 1 BOX09/15/2015
1NDC:70089-100-1060 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/15/2015
Labeler - Natural Crest Laboratories Inc. (050926699)
Establishment
NameAddressID/FEIBusiness Operations
Natural Crest Laboratories Inc.050926699manufacture(70089-100)

Revised: 9/2015
Document Id: 1f82d7ca-4e2a-4550-bc7d-8803fd5c7745
Set id: cff1d197-23f0-457d-aa14-c84a57f07861
Version: 1
Effective Time: 20150915
 
Natural Crest Laboratories Inc.