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

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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Drug Facts

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

Uses
• helps prevent sunbur

Warnings
For 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. 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.
• Children under 6 months of age: ask a doctor

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

image description

CICATRICURE SCAR SPF 30 
avobenzone - 3% octocrylene - 10% oxybenzone - 6% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-034
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene10 g  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-034-0121 mL in 1 TUBE; Type 0: Not a Combination Product03/01/201709/21/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/01/201709/21/2022
Labeler - Genomma Lab (832323534)
Registrant - Product Quest Mfg. (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg.927768135manufacture(50066-034)

Revised: 9/2022
Document Id: 16016093-79cb-4d5a-8cc8-b199a8b49939
Set id: 53595a6f-fcf3-4fad-8e72-dd5d1d1b7650
Version: 3
Effective Time: 20220922
 
Genomma Lab