Label: PYRATINE XR CREME WITH SUNSCREEN BROAD SPECTRUM SPF30- zinc oxide cream
- NDC Code(s): 62742-4145-1, 62742-4145-2
- Packager: Allure Labs Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 7, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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
- QUESTIONS
- STORAGE AND HANDLING
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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
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INGREDIENTS AND APPEARANCE
PYRATINE XR CREME WITH SUNSCREEN BROAD SPECTRUM SPF30
zinc oxide creamProduct 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)
