CALIFORNIA TAN BROAD SPECTRUM SPF 45- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone 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 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.7 %, and Oxybenzone 2 %

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, 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 or Comments?

Call toll free 1-800-SUNCARE

PRINCIPAL DISPLAY PANEL - 133 mL  Tube Label

PRINCIPAL DISPLAY PANEL - 133 mL Tube Label

CALIFORNIA TAN

CT

45

SUNSCREEN LOTION

Broad Spectrum SPF 45

Water Resistant

(80 Minutes)

CLEANTOUCH

TECHNOLOGY

133 mL / 4.5 Fl Oz

CALIFORNIA TAN  BROAD SPECTRUM SPF 45
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0097
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE29.9 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE99.8 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49.9 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27.5 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE19.9 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0097-3133 mL in 1 TUBE; Type 0: Not a Combination Product04/04/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/04/2013
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028label(58443-0097) , pack(58443-0097) , manufacture(58443-0097) , analysis(58443-0097)

Revised: 1/2020
Document Id: 9c59712e-ed48-fa1c-e053-2995a90a0223
Set id: 8ea7a7d5-4c8b-402f-91a3-165567a484e4
Version: 4
Effective Time: 20200117
 
Prime Enterprises, Inc.