CICATRICURE- avobenzone, octinoxate, and octocrylene cream

Cicatricure by

Drug Labeling and Warnings

Cicatricure by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3%	Sunscreen
Octinoxate 7.5%	Sunscreen
Octocrylene 7.5%	Sunscreen

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

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes.

Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating.

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 factor of 15 or higher and other skin protection measures including:

• limit time in the sun, especially from 10am to 2pm
• wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: ask a doctor

Other information

• protect product from excessive heat and direct sun
• may stain some fabrics
• keep this carton for future reference.

Inactive ingredients

Water, Glycerin, Isostearyl Isostearate, Stearyl Monoglyceridyl Citrate, Cetearyl Alcohol, Iron Oxides, Cyclomethicone, Mannitol, Titanium Dioxide, Butylene Glycol, Carbomer, Polysorbate-20, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-38, Decolorized Aloe vera leaf extract, Chamomilla recutita (Chamomile) flower extract, Centella asiatica leaf extract, Juglans regia (Walnut) leaf extract, Oryza sativa (Rice) Bran Oil, Potassium Cetyl Phosphate, Glyceryl Caprylate, Alpha-Tocopheryl Acetate, Hydrogenated Lecithin, Aluminum Hydroxide, Triethoxycaprylylsilane, Polymethyl Methacrylate, Xanthum Gum, Hydroxypropyl Cyclodextrin, Niacinamide, Melanin, Disodium EDTA, Imidazolidinyl Urea, Panthenol, Dimethicone, Methylparaben, Propylparaben

Questions

Call toll free 1 877-994-3666 Monday to Friday, 8am to 6pm, Central time

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Distributed by
Genomma Lab USA Inc.
Houston, TX 77027

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

Cicatricure®

PLASMA

YOUTH ACTIVATING MOISTURIZER

BROAD SPECTRUM SPF 15

With Sunscreen

ADDS MOISTURE & RADIANCE
TO YOUR SKIN ACCORDING
TO YOUR SPECIFIC NEEDS

With MATRIXYL® One of the most advanced
cosmetic ingredients in the last 25 years*

Net Wt.
1 FL OZ (30mL)

INGREDIENTS AND APPEARANCE

CICATRICURE 
avobenzone, octinoxate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-701
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Isostearyl Isostearate (UNII: IV0Z586Z4Y)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Ferric Oxide Red (UNII: 1K09F3G675)
Cyclomethicone (UNII: NMQ347994Z)
Mannitol (UNII: 3OWL53L36A)
Titanium Dioxide (UNII: 15FIX9V2JP)
Butylene Glycol (UNII: 3XUS85K0RA)
Carboxypolymethylene (UNII: 0A5MM307FC)
Polysorbate 20 (UNII: 7T1F30V5YH)
Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R)
Palmitoyl Lysyldioxymethionyllysine (UNII: T7A529FB8O)
Chamomile (UNII: FGL3685T2X)
Centella Asiatica Leaf (UNII: 6810070TYD)
Juglans regia leaf (UNII: 85HKB87105)
Rice Bran Oil (UNII: LZO6K1506A)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Glyceryl Monocaprylate (UNII: TM2TZD4G4A)
Hydrogenated Soybean Lecithin (UNII: H1109Z9J4N)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Poly(Methyl Methacrylate; 450000 MW) (UNII: Z47NNT4J11)
Xanthan Gum (UNII: TTV12P4NEE)
Niacinamide (UNII: 25X51I8RD4)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Imidurea (UNII: M629807ATL)
Panthenol (UNII: WV9CM0O67Z)
Dimethicone (UNII: 92RU3N3Y1O)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-701-01	1 in 1 CARTON	11/01/2017
1		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	11/01/2017

Labeler - Genomma Lab USA (832323534)