Label: INFINITEK PARIS BROAD SPECTRUM SPF 50 SUNSCREEN- titanium dioxide, zinc oxide lotion
- NDC Code(s): 58443-0436-3
- Packager: Prime Enterprises 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 October 26, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Uses
- Purpose
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply:
- After 80 minutes of swimming or sweating.
- Immediately after towel drying.
- At least every 2 hours.
- 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 sun protection measures including:
- Limit time in the sun, especially from 10:00 a.m. to 2:00 p.m.
- Wear long-sleeved shirt, pants, hats, and sunglasses.
- Children under 6 months: Ask a doctor.
- Other Information
- Questions or Comments?
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INACTIVE INGREDIENTS
Allantoin, Alumina, Butyrospermum Parkii (Shea) Butter, Camellia Oleifera (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Cetyl PEG/PPG-10/1 Dimethicone, Cucumis Sativus (Cucumber) Extract, Cyclopentasiloxane, Dimethicone Crosspolymer, Disteardimonium Hectorite, Ethylhexylglycerin, Glycerin, Hexyl Laurate, Iron Oxides, Linum Usitatissimum (Linseed) Seed Oil, Oenothera Biennis (Evening Primrose) Oil, PEG-10 Dimethicone, Phenoxyethanol, Physalis Angulata Extract, Plankton Extract, Polyglyceryl-4 Isostearate, Polymethylsilsesquioxane, Rosa Canina Seed Oil, Silica, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Water
- Infinitek Paris Tinted Mineral Sunscreen Broad Spectrum SPF 50 - 50 mL
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INGREDIENTS AND APPEARANCE
INFINITEK PARIS BROAD SPECTRUM SPF 50 SUNSCREEN
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0436 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 41.84 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 41.84 mg in 1 mL Inactive Ingredients Ingredient Name Strength FERRIC OXIDE RED (UNII: 1K09F3G675) ROSA CANINA SEED OIL (UNII: MHT97MG5P8) ALLANTOIN (UNII: 344S277G0Z) LINSEED OIL (UNII: 84XB4DV00W) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CUCUMBER SEED (UNII: BT3S9L53JK) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) EVENING PRIMROSE OIL (UNII: 3Q9L08K71N) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALUMINUM OXIDE (UNII: LMI26O6933) STEARIC ACID (UNII: 4ELV7Z65AP) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PHYSALIS ANGULATA (UNII: W4TKW9D5GG) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) SHEA BUTTER (UNII: K49155WL9Y) HEXYL LAURATE (UNII: 4CG9F9W01Q) Product Characteristics Color brown (Light Tan) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0436-3 50 mL in 1 TUBE; Type 0: Not a Combination Product 05/20/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/20/2019 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0436) , manufacture(58443-0436) , label(58443-0436) , analysis(58443-0436)
