SCARSCREEN- zinc oxide lotion

ScarScreen by

Drug Labeling and Warnings

ScarScreen by is a Otc medication manufactured, distributed, or labeled by Natural Crest Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 15%

Purpose

Sunscreen

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

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

INGREDIENTS AND APPEARANCE

SCARSCREEN 
zinc oxide lotion

Product 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)