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

Pyratine XR Creme With Sunscreen Broad Spectrum SPF30 by

Drug Labeling and Warnings

Pyratine XR Creme With Sunscreen Broad Spectrum SPF30 by is a Otc medication manufactured, distributed, or labeled by Allure Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Zinc oxide - 18.6%

PURPOSE

Purpose: Sunscreen

INDICATIONS & USAGE

Uses:

• Help prevent sunburn. Higher SPF gives more sunburn protection. Provide high protection against sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS

Warnings: For external use only. Do not use on damaged or broken skin.

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash or irritation developes and lasts.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions:

• For sunscreen use. Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating.
• Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other protection measures including: limit time in the sun, especially from 10 am - 2 pm. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor.

OTHER SAFETY INFORMATION

protect this product from excessive heat and direct sun.

QUESTIONS

Call toll free 1-888-467-9728

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

Developed, Distributed and Marketed by:

Pyratine LLC

2950 Main Street

Morro Bay, CA 93442

1-888-467-9728

www.pyratine.com

INGREDIENTS AND APPEARANCE

PYRATINE XR CREME WITH SUNSCREEN BROAD SPECTRUM SPF30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4145
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	186 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4145-2	1 in 1 CARTON	12/07/2017
1	NDC: 62742-4145-1	56.7 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 final	part352	12/07/2017

Labeler - Allure Labs Inc (926831603)

Registrant - Allure Labs Inc (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs Inc		926831603	manufacture(62742-4145)