Label: ETERNAL SPIRIT BEAUTY BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide lotion
- NDC Code(s): 58443-0413-3
- Packager: Prime Enterprises, Inc.
- Category: HUMAN OTC DRUG LABEL
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 August 26, 2021
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- 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
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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 of 15 or higher and other sun protection measures including:
- limit time in sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
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Inactive Ingredients
Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aluminum Hydroxide, Argania spinosa (Argan) Kernel Oil, C12-15 Alkyl Benzoate, Ceteareth-20, Cetyl Alcohol, Dibutyl Adipate, Dimethicone, Glycerin, Hexyl Laurate, Iron Oxides, Lecithin, Magnesium Aluminum Silicate, Malus Domestica Fruit Cell Culture Extract, Methylisothiazolinone, PEG-12 Dimethicone, Phenoxyethanol, Polyglyceryl-3 Distearate, Stearic Acid, Stearyl Alcohol, Triethoxycaprylylsilane, Water (Aqua), Xanthan Gum
- Other information
- Eternal Spirit Beauty Sunscreen Lotion Broad Spectrum SPF 30 Mineral Sunscreen
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INGREDIENTS AND APPEARANCE
ETERNAL SPIRIT BEAUTY BROAD SPECTRUM SPF 30
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0413 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 31.2 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 41.6 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERIN (UNII: PDC6A3C0OX) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONE (UNII: 92RU3N3Y1O) BROWN IRON OXIDE (UNII: 1N032N7MFO) PEG-12 DIMETHICONE (UNII: ZEL54N6W95) XANTHAN GUM (UNII: TTV12P4NEE) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ARGAN OIL (UNII: 4V59G5UW9X) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETYL ALCOHOL (UNII: 936JST6JCN) DIBUTYL ADIPATE (UNII: F4K100DXP3) FERRIC OXIDE RED (UNII: 1K09F3G675) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) APPLE (UNII: B423VGH5S9) POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) STEARIC ACID (UNII: 4ELV7Z65AP) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Product Characteristics Color brown (Tan) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0413-3 59 mL in 1 TUBE; Type 0: Not a Combination Product 02/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/01/2016 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprises, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 label(58443-0413) , pack(58443-0413) , manufacture(58443-0413) , analysis(58443-0413)
