LYCOGEL COVER AND RECOVERY - BREATHABLE CAMOUFLAGE - SPF 30 WITH LYCO COMPLEX- titanium dioxide and zinc oxide cream

Lycogel Cover and Recovery - Breathable Camouflage - SPF 30 with LYCO Complex by

Drug Labeling and Warnings

Lycogel Cover and Recovery - Breathable Camouflage - SPF 30 with LYCO Complex by is a Otc medication manufactured, distributed, or labeled by Allure Cosmetic, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: 6.5% TITANIUM DIOXIDE

                                    8.2% ZINC OXIDE

INACTIVE INGREDIENT

Inactive Ingredients:
WATER, CYCLOPENTASILOXANE, DIMETHICONE, PEG-10/15 CROSSPOLYMER, CYCLOMETHICONE, SACCHAROMYCES LYSATE EXTRACT, HYDRATED SILICA, PEG/PPG-18/18 DIMETHICONE, MALUS DOMESTICA FRUIT CELL CULTURE, CYPERUS ROOT EXTRACT, LONICERA JAPONICA FLOWER EXTRACT, XANTHIUM SIBIRICUM FRUIT EXTRACT, SODIUM HYALURONATE, SQUALANE (OLIVE), ACETYL TETRAPEPTIDE-15, PHOSPHOLIPIDS, RETINYL PALMITATE, TOCOPHEROL ACETATE, ASCORBYL PALMITATE, BETA-CAROTENE, SANTALUM ALBUM (SANDALWOOD) EXTRACT, PHELLODENDRON AMURENSE BARK EXTRACT, HORDEUM DISTICHON (BARLEY) EXTRACT, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, ALGAE EXTRACT, ARTEMISIA VULGARIS EXTRACT, ZINC PCA, CENTELLA ASIATICA EXTRACT, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ACRYLATES ETHYLHEXYL ACRYLATE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL  HEXYL DIMETHICONE, XANTHAN GUM, GLYCERIN, LECITHIN, MANNITOL, SODIUM CITRATE, ALUMINUM HYDROXIDE, STEARIC ACID, PHENOXYETHANOL, ISOHEXADECANE, CAPRYLYL GLYCOL, ETHYLHEXYLGYCERINE, HEXYLENE GLYCOL, SODIUM BENZOATE.
MAY CONTAIN: Cl 77491, Cl 77492, Cl 77499 (IRON OXIDE), Cl 77891 (TITANIUM DIOXIDE)

PRINCIPAL DISPLAY PANEL

Information on Carton Label:

1. Principal Display Panel: Shown in the image below.

2. Back Panel:

Manufactured for and distributed by

Quura Medical, BV. 1272 CB, The Netherlands

www.lycogel.eu

-------------------------------------------

Active Ingredients:

Inactive Ingredients:

(as listed above)

Warning: For external use only. Avoid contact with eyes. Discontinue use if irritation occurs and consult your skin specialist.

3. Side Panel A: Lycogel Cover and Recovery

4. Side Panel B: Use Benefits

The first breathable colour corrective treatment that combines cosmetic and skincare technology to promote post procedure healing, soothe sensitive skin, rejuvenate and camouflage at the same time.

Lycogel's  revolutionary technology combines a unique breathable Tripple Silica Gel Base with LYCO Complex, a carefully balanced set of bio-active agents that work synergistically to improve the skin.

Directions: Dispense a small amount and apply with clean sponge or fingertips. Apply in buildable layers for more coverage using a patting technique.

5.Top: Cover and Recovery printed in white on gray background.

6. Bottom: Shade name sticker (Almond, Caramel, Creme, Honey, Green, Pink, Beige, Taupe, Cocoa, Ebony, Ivory, Tawny, Oaker, and Yellow)

INGREDIENTS AND APPEARANCE

LYCOGEL COVER AND RECOVERY - BREATHABLE CAMOUFLAGE - SPF 30 WITH LYCO COMPLEX 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE)	TITANIUM DIOXIDE	65 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC OXIDE	82 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
APPLE (UNII: B423VGH5S9)
CYPERUS ROTUNDUS ROOT (UNII: 4B51SRR959)
XANTHIUM (UNII: 8555ORT735)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SQUALANE (UNII: GW89575KF9)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BETA CAROTENE (UNII: 01YAE03M7J)
PHELLODENDRON AMURENSE (UNII: PBG27B754G)
BARLEY (UNII: 5PWM7YLI7R)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MANNITOL (UNII: 3OWL53L36A)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4031-2	1 in 1 CARTON
1	NDC: 62742-4031-1	20 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/01/2010

Labeler - Allure Cosmetic, Inc. (926831603)

Registrant - Allure Cosmetic, Inc. (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Cosmetic, Inc.		926831603	manufacture