COVER RECOVER SPF 30 SAND- zinc oxide and titanium dioxide cream

Cover Recover SPF 30 Sand by

Drug Labeling and Warnings

Cover Recover SPF 30 Sand by is a Otc medication manufactured, distributed, or labeled by Allure Labs, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 8.5%

Titanium Dioxide 6.5%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Uses: Helps prevent sunburn.

if used as directed with other sun protection measures, decreases the rsk of skin cancer and early skin aging caused by the sun.

post treatment camouflage for skin needling and rejuvenation procedures.

DOSAGE & ADMINISTRATION

Directions: Apply immediately after treatment procedures, to dry clean skin, as a acamouflage for minor skin trauma. Apply daily after your skincare regime with DPDermaceuticals, as a corrective sunscreen foundation.

Sun protection measures: For sunscreen use

Apply for liberally 15 minutes before sun exposure. Re-apply every 2 hours, or after swimming or drying off with a towel. Prolonged exposure to the sun should be avoided, especially from 10:00am - 2:00pm. Suitable clothing such as long-sleeved shirt, hats, and sunglasses should be worn at all times in the sun. Use on children under 6 months ask a doctor. 

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.

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENT

Cyclopentasiloxane, Dimethicone, Water (Aqua), Polyglyceryl-3-Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Bismuth Oxychloride, Butylene Glycol, Hydroxypropylcocoate PE-8 Dimethicone, Polyglyceryl-2 Diisostearate, Hydrated Silica, Mica, Stearic Acid, Aluminum Hydroxide, Dimethicone/Vinyl Dimethicone Crosspolymer, Jojoba Esters, Cyclohexasiloxane, Biosaccharide Gum-1, Isohexadecane, PEG/PPG-18/18 Dimethicone, Glycerin, Pyrus Malus (Apple) Fruit Extract, Vitis Vinifera (Grape) Seed Extract, Mentha Piperita (Peppermint) Extract, Menthyl PCA, Sodium Hyaluronate, Copper Lysinate/Rolinate, Allantoin, Beta-Carotene, Hydrolyzed Vegetable Protein, Tocopherol, Adenosine Triphosphate, Saccharomyces Lysate Extract, Acetyl Tyrosine, Methylglucoside Phosphate, Retinyl Palmitate, Ascorbyl palmitate, Phospholipids, Proline, Ethyl menthane carboxamide, Triethoxysilylethyl Polydimethylsiloxyethyl HexylDimethicone, Phenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, Caprylyl Glycol, Fragrance (Parfum), Triethoxycaprylysilane, Limonene, Linalool, citral, May contain:(+/-) Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

PRINCIPAL DISPLAY PANEL

DML42141/GMP Certified.

manufactured in USA for 

EQUIPMED EUROPE LONDON, W1H 1PJ

Made exclusively for www.dermapenworld.com

INGREDIENTS AND APPEARANCE

COVER RECOVER SPF 30 SAND 
zinc oxide and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	85.0 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	65.0 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
MICA (UNII: V8A1AW0880)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
TRIEPOXYCYCLOHEXASILANE (UNII: 066Q83563R)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
ISOHEXADECANE (UNII: 918X1OUF1E)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
GLYCERIN (UNII: PDC6A3C0OX)
APPLE (UNII: B423VGH5S9)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
MENTHYL DL-PYRROLIDONECARBOXYLATE (UNII: 8P18J856U2)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALLANTOIN (UNII: 344S277G0Z)
.BETA.-CAROTENE (UNII: 01YAE03M7J)
TOCOPHEROL (UNII: R0ZB2556P8)
ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
N-ACETYLTYROSINE (UNII: DA8G610ZO5)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
PROLINE (UNII: 9DLQ4CIU6V)
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+)- (UNII: F4VNO44C09)
CITRAL (UNII: T7EU0O9VPP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4123-2	1 in 1 CARTON	12/05/2017
1	NDC: 62742-4123-1	20 mL 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 final	part352	12/05/2017

Labeler - Allure Labs, Inc (926831603)

Registrant - Allure Labs, Inc (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs, Inc		926831603	manufacture(62742-4123)