CALIFORNIA TAN SPF 30 SUNSCREEN- 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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California Tan SPF 30 Sunscreen Lotion

Active Ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocrylene 2.75%

Oxybenzone 2%

Sunscreen

Uses

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

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?

Call toll free 1-855-LIV-GOLD (548-4653)

California Tan SPF 30 Sunscreen Lotion

Principle Display Panel

CALIFORNIA TAN  SPF 30 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0202
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE20 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0202-4133 mL in 1 BOTTLE; Type 0: Not a Combination Product04/02/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/02/2014
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0202) , manufacture(58443-0202) , label(58443-0202)

Revised: 1/2020
Document Id: 9c581ab7-5837-484b-e053-2a95a90a6e7b
Set id: 2393ef7e-c7d8-07b4-e054-00144ff88e88
Version: 3
Effective Time: 20200117
 
Prime Enterprises Inc.