TINTED CLEAR ZINC SOLAR PROTECTION SPF 30- zinc oxide cream

Tinted Clear Zinc Solar Protection SPF 30 by

Drug Labeling and Warnings

Tinted Clear Zinc Solar Protection SPF 30 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 17.67%

DOSAGE & ADMINISTRATION

Directions: Masasge onto skin with fingertips, and reapply as needed. Avoid eye area while applying.

For external use only.

INACTIVE INGREDIENT

Other Ingredients: Water (Aqua), Cyclopentasiloxane, Dimethcone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crossploymer, Polyglyceryl-3 polydimethylsiloxyethyl Dimethicone, Cyclomethicone, PEG/PPG-18/18 Dimethicone, Hexyl triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, C12-15 Alkul benzoate, Poluisobutene, Isododecane, Phenoxyethanol, Sodium Hyaluronate, Caprylyl Glycol, Tocopheryl Acetate, Ethylhexylglycerin, Hexylene Glycol, Mica, Aloe barbadensis Leaf extract, Camellia Sinensis Leaf extract, Olea Europaea (Olive) Leaf Extarct, Silica, Titanium Dioxide, Iron Oxides

PRINCIPAL DISPLAY PANEL

Physicians Aesthetic

Research, Inc.

www.lucrece.com

INGREDIENTS AND APPEARANCE

TINTED CLEAR ZINC SOLAR PROTECTION SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	176.7 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
CYCLOMETHICONE (UNII: NMQ347994Z)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
MICA (UNII: V8A1AW0880)
ALOE (UNII: V5VD430YW9)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
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: 62742-4112-1	71 g in 1 TUBE; Type 0: Not a Combination Product	12/04/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/04/2017

Labeler - Allure Labs, Inc (926831603)

Registrant - Allure Labs, Inc (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs, Inc		926831603	manufacture(62742-4112)