![UNITED SPIRIT OF AMERICA BROAD SPECTRUM SPF 50 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PRIME ENTERPRISES INC.]](https://medic.hrt.org//dailymed/images/3b87d291-a1a1-37ed-e054-00144ff8d46c/58443-0240-3 (3).jpg)
| NDC | 58443-0240-3 |
| Set ID | 3b87d291-a1a1-37ed-e054-00144ff8d46c |
| 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 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 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 INGREDIENT
Allantoin, Aluminum Hydroxide, C12-15 Alkyl Benzoate, Camellia Oleifera (Green Tea) Leaf Extract, Caprylyl Glycol, Ceteareth-20, Cetyl Alcohol, Dibutyl Adipate, Glycerin, Hexyl Laurate, Magnesium Aluminum Silicate, Methylcellulose, Octyldodecyl Citrate Crosspolymer, Phenoxyethanol, Polyglyceryl-3 Distearate, Stearic Acid, Stearyl Alcohol, Triethoxycaprylylsilane, VP/Eicosene Copolymer, Water, Xanthan Gum
- Other Information
- United Spirit of America Broad Spectrum SPF 50 Sunscreen
-
INGREDIENTS AND APPEARANCE
UNITED SPIRIT OF AMERICA BROAD SPECTRUM SPF 50 SUNSCREEN
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0240 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 44.6 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 39.6 mg in 1 mL Inactive Ingredients Ingredient Name Strength STEARIC ACID (UNII: 4ELV7Z65AP) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETYL ALCOHOL (UNII: 936JST6JCN) DIBUTYL ADIPATE (UNII: F4K100DXP3) METHYLCELLULOSE (15 CPS) (UNII: NPU9M2E6L8) OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M) POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV) ALLANTOIN (UNII: 344S277G0Z) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) XANTHAN GUM (UNII: TTV12P4NEE) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) HEXYL LAURATE (UNII: 4CG9F9W01Q) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) GLYCERIN (UNII: PDC6A3C0OX) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0240-3 88.7 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/16/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/11/2016 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0240) , manufacture(58443-0240) , label(58443-0240) , analysis(58443-0240)
