CICATRICURE BRIGHTENING FACE WITH SPF- avobenzone, homosalate, octinoxate, octisalate, and oxybenzone cream

Cicatricure Brightening With SPF by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
OCTINOXATE, 7.5%	Sunscreen
OCTISALATE, 4.5%	Sunscreen
HOMOSALATE, 4.5%	Sunscreen
OXYBENZONE, 3%	Sunscreen
AVOBENZONE, 1%	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, ALCOHOL, POLYSORBATE 60, SORBITAN STEARATE, BUTYLENE GLYCOL, TRIETHANOLAMINE, CARBOMER, BENZYL ALCOHOL, PHENOXYETHANOL, METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER, FRAGRANCE, POLYSORBATE 20, HYDROLYZED OAT PROTEIN, PPG-2 MYRISTYL ETHER PROPIONATE, ETHYL ASCORBIC ACID, ALPHA-ARBUTIN, ETHYLHEXYLGLYCERIN, SILANEDIOL SALICYLATE, MELANIN, PALMITOYL TRIPEPTIDE-1, PALMITOYL TETRAPEPTIDE-7.

Questions

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

SPL UNCLASSIFIED SECTION

Distributed by:
Genomma Lab USA Inc.
Houston, TX 77027

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

NEW

With Sunscreen

Cicatricure®
BRIGHTENING FACE CREAM

Exclusive formula *QAcetyl 10®
& NUTRI-ACLARANT

• Unifies Skin tone
• Reduces appearance of
  wrinkles
• Moisturizes & nourishes

SPF 20

Younger-looking skin in 2 weeks

2
Weeks

Net. Wt. 1.6 FL OZ (50 mL)

INGREDIENTS AND APPEARANCE

CICATRICURE BRIGHTENING FACE WITH SPF 
avobenzone, homosalate, octinoxate, octisalate, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-704
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	10 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	45 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	45 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
glycerin (UNII: PDC6A3C0OX)
Polysorbate 60 (UNII: CAL22UVI4M)
Polysorbate 20 (UNII: 7T1F30V5YH)
Sorbitan Monostearate (UNII: NVZ4I0H58X)
Butylene glycol (UNII: 3XUS85K0RA)
Carboxypolymethylene (UNII: 0A5MM307FC)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-704-01	1 in 1 CARTON	10/07/2019
1		50 mL in 1 BOTTLE, PLASTIC; 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	10/07/2019

Labeler - Genomma Lab USA (832323534)