CALIFORNIA TAN BROAD SPECTRUM SPF 15- avobenzone, octisalate, and octocrylene lotion 
Prime Enterprises, Inc.

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.

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Active ingredients

Avobenzone 2 %, Octisalate 5 %, and Octocrylene 1.85 %

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Adenosine Cyclic Phosphate, Adenosine Triphosphate, Butylphthalimide, C12-15 Alkyl Benzoate, 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 Difluorohydroxyethyl PEG Phosphate, Polysilicone-15, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Pyruvic Acid, Saccharomyces Calcium Ferment, Saccharomyces Lysate Extract, Saccharomyces Magnesium Ferment, Saccharomyces Zinc Ferment, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Water (Aqua)

Other information

Questions or Comments?

Call toll free 1-800-SUNCARE

PRINCIPAL DISPLAY PANEL - 133 mL  Tube Label

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Label


CALIFORNIA TAN

CT

15

SUNSCREEN LOTION

Broad Spectrum SPF 15

Water Resistant

(80 Minutes)

CLEANTOUCH™

TECHNOLOGY

4.5 FL Oz (133 mL)

CALIFORNIA TAN  BROAD SPECTRUM SPF 15
avobenzone, octisalate, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0095
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE19.3 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE48.2 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE26.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N)  
ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
COLEUS FORSKOHLII ROOT OIL (UNII: 5NXR7DJ9WO)  
N,N-DIMETHYL-2-OCTADECANAMINE (UNII: C358MC5735)  
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)  
MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
AMINO ACIDS (UNII: 0O72R8RF8A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
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)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0095-3133 mL in 1 TUBE; Type 0: Not a Combination Product04/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2013
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028label(58443-0095) , pack(58443-0095) , manufacture(58443-0095) , analysis(58443-0095)

Revised: 1/2020
Document Id: 9c595e63-0904-3358-e053-2995a90a54c4
Set id: 7cb3bfc3-d957-4ba2-97cf-464073fdbbd7
Version: 3
Effective Time: 20200117
 
Prime Enterprises, Inc.