CICATRICURE SCAR SPF 30- avobenzone - 3% octocrylene - 10% oxybenzone - 6% cream

Cicatricure Scar SPF 30 by

Drug Labeling and Warnings

Cicatricure Scar SPF 30 by is a Otc medication manufactured, distributed, or labeled by Genomma Lab, Product Quest Mfg.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                        Purpose
Avobenzone 3% ......................................... Sunscreen
Octocrylene, 10% ....................................... Sunscreen
Oxybenzone 6% ......................................... Sunscreen

PURPOSE

INDICATIONS & USAGE

Uses
helps prevent sunbur

WarningsFor External use only

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer and early skin aging.
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

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

DOSAGE & ADMINISTRATION

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.
Children under 6 months of age: ask a doctor

INACTIVE INGREDIENT

Inactive ingredients
Water, Allium Cepa (Onion) Bulb Extract, Sorbitan
Isostearate, Sorbitol, Polyester-7, VP/Eicosene
Copolymer, Glyceryl Caprylate, decolorized Aloe
Barbadensis (Aloe) Leaf Extract, Chamomilla Recutita
(Chamomile) Flower Extract, Simmondsia Chinensis
(Jojoba) Seed Oil, Lepidium Sativum (Cress) Sprout
Extract, Allantoin, Tocopherol, Stearic Acid,
Polysorbate 80, Carbomer, Dimethicone, Disodium
EDTA, Lecithin, Glycerin, Neopentyl Glycol
Diheptanoate, Polyglyceryl-3 Distearate, Benzyl
Alcohol, Triethanolamine, Phenoxyethanol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CICATRICURE SCAR SPF 30 
avobenzone - 3% octocrylene - 10% oxybenzone - 6% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-034
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	3 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	10 g  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	Oxybenzone	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
ONION (UNII: 492225Q21H)
Sorbitan Isostearate (UNII: 01S2G2C1E4)
Sorbitol (UNII: 506T60A25R)
Polyester-7 (UNII: 0841698D2F)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
JOJOBA OIL (UNII: 724GKU717M)
GARDEN CRESS SPROUT (UNII: PWQ18YNR62)
Allantoin (UNII: 344S277G0Z)
Tocopherol (UNII: R0ZB2556P8)
Stearic Acid (UNII: 4ELV7Z65AP)
Polysorbate 80 (UNII: 6OZP39ZG8H)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
Dimethicone (UNII: 92RU3N3Y1O)
Propylene Glycol (UNII: 6DC9Q167V3)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Glycerin (UNII: PDC6A3C0OX)
Neopentyl Glycol Diheptanoate (UNII: 5LKW3C543X)
Polyglyceryl-3 Distearate (UNII: ZI1LK470XV)
Benzyl Alcohol (UNII: LKG8494WBH)
TROLAMINE (UNII: 9O3K93S3TK)
Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-034-01	21 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/01/2017

Labeler - Genomma Lab (832323534)

Registrant - Product Quest Mfg. (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg.		927768135	manufacture(50066-034)