Label: SCARSCREEN- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 70089-100-10, 70089-100-11 - Packager: Natural Crest Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated September 15, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- Uses
- Warnings
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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.
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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
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SPL UNCLASSIFIED SECTION
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
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INGREDIENTS AND APPEARANCE
SCARSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70089-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.75 g in 5 mL Inactive Ingredients Ingredient Name Strength 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 Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70089-100-11 1 in 1 BOX 09/15/2015 1 NDC:70089-100-10 60 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/15/2015 Labeler - Natural Crest Laboratories Inc. (050926699) Establishment Name Address ID/FEI Business Operations Natural Crest Laboratories Inc. 050926699 manufacture(70089-100)
