SCAR CREAM SPF 30- avobenzone, octocrylene, oxybenzone cream

Scar Cream SPF 30 by

Drug Labeling and Warnings

Scar Cream SPF 30 by is a Otc medication manufactured, distributed, or labeled by Genomma Lab, CGI Packaging, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

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 eyes 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

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: ask a doctor.

Inactive Ingredients

Water, Allium Cepa (Onion) Bulb Extract, Sorbitan Isostearate, Sorbitol, Polyester-7, VP/Eicosene Copolymer, Glyceryl Caprylate, decolorized Aloe Barbadensis Leaf Extract, Chamomilla Recutita 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

Label

INGREDIENTS AND APPEARANCE

SCAR CREAM SPF 30 
avobenzone, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-019
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 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
MATRICARIA RECUTITA LEAF (UNII: 6I9LN466F0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE 200 (UNII: RGS4T2AS00)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
WATER (UNII: 059QF0KO0R)
ONION (UNII: 492225Q21H)
SORBITOL (UNII: 506T60A25R)
POLYESTER-7 (UNII: 0841698D2F)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ALLANTOIN (UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
STEARIC ACID (UNII: 4ELV7Z65AP)
GARDEN CRESS SPROUT (UNII: PWQ18YNR62)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TROLAMINE (UNII: 9O3K93S3TK)
JOJOBA OIL (UNII: 724GKU717M)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-019-01	1 in 1 CARTON	01/07/2019
1		19.8 g in 1 TUBE; 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	01/07/2019

Labeler - Genomma Lab (832323534)

Registrant - CGI Packaging, LLC (080691099)

Establishment
Name	Address	ID/FEI	Business Operations
CGI Packaging, LLC		080691099	manufacture(50066-019)