PYRATINE XR CREME WITH SUNSCREEN BROAD SPECTRUM SPF30- zinc oxide cream 
Allure Labs Inc

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 Ingredient: Zinc oxide - 18.6%

Purpose: Sunscreen

Uses:

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 or irritation developes and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Cpntrol center right away.

Directions:

protect this product from excessive heat and direct sun.

Call toll free 1-888-467-9728

Store at controlled room temperature 59 F - 89 F (15 C - 30 C).

Inactive Ingredients: Water (Aqua), Cyclopentasiloxane, Butylene glycol, glycerin, Propylene Glycol, Caprylic/Capric triglyceride, Glycerin Stearate, PEG-100 Stearate, Polyglyceryl-3 Polymethylsiloxyeethyl Dimethicon, Cyclohexasiloxane, Sorbitan Stearate, Dimethicone, Polyacrylamide, C13-14 Isoparaffin, Laureth-7,phenoxyethanol, Caprylyl Glycol, Ethylhexyglycerin, Hexylene glycol, Imperata Cylindrica Root Extract, PEG-8, Carbomer, triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol, Lecithin, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Xanthan gum, Furfuryl Tetrahydropyranyladinine, tocopherol Linoleate/Oleate, Teprenone, Phoenix Dactylifera (Date) Fruit Extract, Sodium Lactate, Disodium EDTA, Dipotassium Glycyrrhizate, Arabidopsis Thaliana Extract, Plankton Extract and Micrococcus Lysate.

Developed, Distributed and Marketed by:

Pyratine LLC

2950 Main Street

Morro Bay, CA 93442

1-888-467-9728

www.pyratine.com

Image Pyratine XR

Image Pyratine XR

PYRATINE XR CREME WITH SUNSCREEN BROAD SPECTRUM SPF30 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4145
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION186 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
CARBOMER 1342 (UNII: 809Y72KV36)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYESTER-7 (UNII: 0841698D2F)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
.ALPHA.-TOCOPHEROL LINOLEATE, D- (UNII: G0N132Q0ED)  
TEPRENONE (UNII: S8S8451A4O)  
DATE (UNII: H3O7QI5HY7)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4145-21 in 1 CARTON12/07/2017
1NDC:62742-4145-156.7 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/07/2017
Labeler - Allure Labs Inc (926831603)
Registrant - Allure Labs Inc (926831603)
Establishment
NameAddressID/FEIBusiness Operations
Allure Labs Inc926831603manufacture(62742-4145)

Revised: 12/2017
Document Id: 8e9f9e3a-6bd4-4a35-b859-ad14ff81e53b
Set id: fc316b19-c1cf-4b5b-9f22-9672b7d0cbff
Version: 1
Effective Time: 20171207
 
Allure Labs Inc