![WARRIOR BROAD SPECTRUM SPF 30 SUNSCREEN MINERALS FORMULA (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PRIME ENTERPRISES INC.]](https://medic.hrt.org//dailymed/images/68032d3a-4a54-6e46-e053-2991aa0ababf/58443-0258-3 (2).jpg)
| NDC | 58443-0258-3 |
| Set ID | 68032d3a-4a54-6e46-e053-2991aa0ababf |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Prime Enterprises Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- Active Ingredients
- Purpose
- Uses
- Warnings
-
Directions
- apply liberally 15 minutes before sun exposure
- reapply
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every two 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 broad spectrum SPF of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: ask a doctor
-
Inactive Ingredients
Acrylates/C12-22 Alkyl Methacrylate Copolymer, Allantoin, Alumina, Aluminum Starch Octenylsuccinate, Camellia Oleifera (Green Tea) Leaf Extract, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Disodium EDTA, Disteardimonium Hectorite, Ethylhexylglycerin, Glycerin, Hexyl Laurate, Isotridecyl Isononanoate, PEG-10 Dimethicone, Phenoxyethanol, Polyglyceryl-4 Isostearate, Polymethylsilsesquioxane, Sodium Chloride, Stearic Acid, Tocopheryl Acetate, Trimethylsiloxysilicate, Water
- Other Information
- Warrior 30 Broad Spectrum SPF 30 Sunscreen Minerals Formula
-
INGREDIENTS AND APPEARANCE
WARRIOR BROAD SPECTRUM SPF 30 SUNSCREEN MINERALS FORMULA
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0258 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 36.33 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 31.14 mg in 1 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) HEXYL LAURATE (UNII: 4CG9F9W01Q) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2) DIMETHICONE (UNII: 92RU3N3Y1O) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT) SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P) ALLANTOIN (UNII: 344S277G0Z) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) Product Characteristics Color white (Off White) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0258-3 88.7 mL in 1 TUBE; Type 0: Not a Combination Product 03/13/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/05/2018 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0258) , manufacture(58443-0258) , label(58443-0258) , analysis(58443-0258)
