Label: PAULAS CHOICE BROAD SPECTRUM SPF 50- avobenzone, octinoxate, octisalate, octocrylene lotion
- NDC Code(s): 58443-0660-3
- Packager: Prime Enterprises
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 17, 2024
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
- SHAKE WELL. Apply liberally 15 minutes before sun exposure
- Use a water-resistant sunscreen if swimming or sweating
- Reapply:
- immediately after towel drying
- at least every two hours
- children under 6 months of age: ask a doctor
- 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 the sun, especially from 10 am - 2 pm
- wear long-sleeve shirts, pants, hats and sunglasses
- Other Information
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Inactive Ingredients
Water, Glycerin, Silica, 3-O-Ethyl Ascorbic Acid, Ascorbyl Glucoside, Dimethicone, Propanediol, Tetrahexyldecyl Ascorbate, Acetyl Zingerone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Diethylhexyl Syringylidenemalonate, Dimethicone/Vinyl Dimethicone Crosspolymer, Entada Phaseoloides Bark/Seed Extract, Porphyra Umbilicalis Extract, Hydrogenated Lecithin, Ricinus Communis (Castor) Seed Oil, Sodium Hydroxide, Tocopherol, Xanthan Gum, Ethylhexylglycerin, Laureth-4, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Titanium Dioxide, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAULAS CHOICE BROAD SPECTRUM SPF 50
avobenzone, octinoxate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0660 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 21 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 78.75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 52.5 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 21 mg in 1 mL Inactive Ingredients Ingredient Name Strength RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM BENZOATE (UNII: OJ245FE5EU) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) XANTHAN GUM (UNII: TTV12P4NEE) LAURETH-4 (UNII: 6HQ855798J) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) BROWN IRON OXIDE (UNII: 1N032N7MFO) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) ACETYL ZINGERONE (UNII: V9D92S9YE5) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) ENTADA PHASEOLOIDES SEED (UNII: 4R80X8KTM7) PORPHYRA UMBILICALIS (UNII: 14AN0J70WO) SODIUM HYDROXIDE (UNII: 55X04QC32I) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PROPANEDIOL (UNII: 5965N8W85T) ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V) PHENOXYETHANOL (UNII: HIE492ZZ3T) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) FERRIC OXIDE RED (UNII: 1K09F3G675) WATER (UNII: 059QF0KO0R) 3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P) Product Characteristics Color brown (Nude/Peach) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0660-3 60 mL in 1 TUBE; Type 0: Not a Combination Product 05/17/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/17/2024 Labeler - Prime Enterprises (101946028) Registrant - Prime Enterprises (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises 101946028 analysis(58443-0660) , label(58443-0660) , manufacture(58443-0660) , pack(58443-0660)
