Label: CALIFORNIA TAN SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0202-4 - 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.
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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
- 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
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INACTIVE INGREDIENT
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Adenosine Cyclic Phosphate, Adenosine Triphosphate, Butylphthalimide, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Coleus Forskohlii Root Extract, Disodium EDTA, Fragrance (Parfum), Glucose, Hydrolyzed Soy Protein, Isopropylphthalimide, Lycium Barbarum (Goji Berry) Fruit Extract, Methylisothiazolinone, Micrococcus Lysate, Phenoxyethanol, Phenyl Trimethicone, Phospholipids, Plant Amino Acids, Polyethylene, Polyperfluoroethoxymethoxy Difluoroethyl PEG Phosphate, Polysilicone-15, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Pyruvic Acid, Saccharomyces Lysate Extract, Saccharomyces/Calcium Ferment, Saccharomyces/Magnesium Ferment, Saccharomyces/Zinc Ferment, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Water (Aqua)
- Other Information
- Questions or Comments?
- California Tan SPF 30 Sunscreen Lotion
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INGREDIENTS AND APPEARANCE
CALIFORNIA TAN SPF 30 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0202 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 20 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 27.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength STEARYL ALCOHOL (UNII: 2KR89I4H1Y) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PYRUVIC ACID (UNII: 8558G7RUTR) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) AMINO ACIDS (UNII: 0O72R8RF8A) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX) LYCIUM BARBARUM FRUIT (UNII: 930626MWDL) ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N) ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE) PHENOXYETHANOL (UNII: HIE492ZZ3T) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) POLYSILICONE-15 (UNII: F8DRP5BB29) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DEXTROSE (UNII: IY9XDZ35W2) (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CETYL ALCOHOL (UNII: 936JST6JCN) N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E) COLEUS FORSKOHLII ROOT OIL (UNII: 5NXR7DJ9WO) SOY PROTEIN (UNII: R44IWB3RN5) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329) 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:58443-0202-4 133 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/02/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/02/2014 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0202) , manufacture(58443-0202) , label(58443-0202)
