Label: CALIFORNIA TAN BROAD SPECTRUM SPF 45- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0097-3 - 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 January 17, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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 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
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Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Adenosine Cyclic Phosphate, Adenosine Triphosphate, Butylated Hydroxytoluene, Butylphthalimide, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Coelus Forskohlii Extract, Disodium EDTA, Fragrance (Parfum), Glucose, Hydrolyzed Soy Protein, Isopropylphthalimide, Lycium Barbarum (Goji Berry) Fruit Extract, Methylisothiazolinone, Methylparaben, Micrococcus Lysate, Phenyl Trimethicone, Phospholipids, Plant Amino Acids, Polyethylene, Polyperfluoroethoxymethoxy Difluorohydroxyethyl PEG Phosphate, Polysilicone-15, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Propylparaben, Pyruvic Acid, Saccharomyces Calcium Ferment, Saccharomyces Lysate Extract, Saccharomyces Magnesium Ferment, Saccharomyces Zinc Ferment, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Water (Aqua)
- Other information
- QUESTIONS
- PRINCIPAL DISPLAY PANEL - 133 mL Tube Label
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INGREDIENTS AND APPEARANCE
CALIFORNIA TAN BROAD SPECTRUM SPF 45
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0097 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 29.9 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 99.8 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 49.9 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 27.5 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 19.9 mg in 1 mL Inactive Ingredients Ingredient Name Strength POLYSILICONE-15 (UNII: F8DRP5BB29) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) PYRUVIC ACID (UNII: 8558G7RUTR) CALCIUM (UNII: SY7Q814VUP) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) MAGNESIUM (UNII: I38ZP9992A) ZINC (UNII: J41CSQ7QDS) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) STYRENE (UNII: 44LJ2U959V) WATER (UNII: 059QF0KO0R) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N) ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 3-BUTYLPHTHALIDE (UNII: 822Q956KGM) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CETYL ALCOHOL (UNII: 936JST6JCN) PLECTRANTHUS BARBATUS ROOT (UNII: V5741391RG) EDETATE DISODIUM (UNII: 7FLD91C86K) DEXTROSE (UNII: IY9XDZ35W2) SOY PROTEIN (UNII: R44IWB3RN5) ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329) LYCIUM BARBARUM FRUIT (UNII: 930626MWDL) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLPARABEN (UNII: A2I8C7HI9T) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) AMINO ACIDS (UNII: 0O72R8RF8A) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0097-3 133 mL in 1 TUBE; Type 0: Not a Combination Product 04/04/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/04/2013 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprises, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 label(58443-0097) , pack(58443-0097) , manufacture(58443-0097) , analysis(58443-0097)
