CICATRICURE

Main information

  • Trade name:
  • CICATRICURE- avobenzone, octinoxate, and octocrylene cream
  • Composition:
  • Avobenzone 30 mg in 1 mL
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CICATRICURE- avobenzone, octinoxate, and octocrylene cream
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • - 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

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 50066-701-01
  • Last update:
  • 21-06-2019

Summary of Product characteristics: dosage, interactions, side effects

CICATRICURE- avobenzone, octinoxate, and octocrylene cream

Genomma Lab USA

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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Cicatricure

Drug Facts

Active ingredients

Purpose

Avobenzone 3%

Sunscreen

Octinoxate 7.5%

Sunscreen

Octocrylene 7.5%

Sunscreen

Us es

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

Ques tions

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

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)

®

®

CICATRICURE

avobenzone, octinoxate, and octocrylene cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 0 6 6 -70 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Avo benzo ne (UNII: G6 3QQF2NOX) (Avo benzo ne - UNII:G6 3QQF2NOX)

Avo be nz o ne

30 mg in 1 mL

O ctino xa te (UNII: 4Y5P7MUD51) (Octino xate - UNII:4Y5P7MUD51)

O c tino xa te

75 mg in 1 mL

O cto crylene (UNII: 5A6 8 WGF6 WM) (Octo crylene - UNII:5A6 8 WGF6 WM)

O c to c ryle ne

75 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Glycerin (UNII: PDC6 A3C0 OX)

Iso stea ryl Iso stea ra te (UNII: IV0 Z58 6 Z4Y)

Ceto stea ryl Alco ho l (UNII: 2DMT128 M1S)

Ferric O xide Red (UNII: 1K0 9 F3G6 75)

Cyclo methico ne (UNII: NMQ3479 9 4Z)

Ma nnito l (UNII: 3OWL53L36 A)

Tita nium Dio xide (UNII: 15FIX9 V2JP)

Butylene Glyco l (UNII: 3XUS8 5K0 RA)

Ca rbo xypo lymethylene (UNII: 0 A5MM30 7FC)

Po lyso rba te 2 0 (UNII: 7T1F30 V5YH)

Pa lmito yl Tetra peptide-7 (UNII: Q41S46 4P1R)

Pa lmito yl Lysyldio xymethio nyllysine (UNII: T7A529 FB8 O)

Cha mo mile (UNII: FGL36 8 5T2X)

Centella Asia tica Lea f (UNII: 6 8 10 0 70 TYD)

Jug la ns reg ia lea f (UNII: 8 5HKB8 710 5)

Rice Bra n O il (UNII: LZO6 K150 6 A)

Po ta ssium Cetyl Pho spha te (UNII: 0 3KCY6 P7UT)

Glyceryl Mo no ca pryla te (UNII: TM2TZD4G4A)

Hydro g ena ted So ybea n Lecithin (UNII: H110 9 Z9 J4N)

Aluminum Hydro xide (UNII: 5QB0 T2IUN0 )

Trietho xyca prylylsila ne (UNII: LDC331P0 8 E)

Po ly( Methyl Metha cryla te; 4 50 0 0 0 MW) (UNII: Z47NNT4J11)

Xa ntha n Gum (UNII: TTV12P4NEE)

Nia cina mide (UNII: 25X51I8 RD4)

Edeta te Diso dium Anhydro us (UNII: 8 NLQ36 F6 MM)

Imidurea (UNII: M6 29 8 0 7ATL)

Pa ntheno l (UNII: WV9 CM0 O6 7Z)

Dimethico ne (UNII: 9 2RU3N3Y1O)

Methylpa ra ben (UNII: A2I8 C7HI9 T)

Pro pylpa ra ben (UNII: Z8 IX2SC1OH)

Product Characteristics

Genomma Lab USA

Color

WHITE

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:50 0 6 6 -70 1-

1 in 1 CARTON

11/0 1/20 17

1

30 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt352

11/0 1/20 17

Labeler -

Genomma Lab USA (832323534)

Revised: 10/2017