CALIFORNIA TAN BROAD SPECTRUM SPF 8- avobenzone, 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 Sunscreen Lotion Broad Spectrum SPF 8

Active ingredients

Avobenzone 0.5 %, Octocrylene 2 %, and Oxybenzone 1.5 %

Purpose

Sunscreen

Uses

  • helps prevent sunburn

Warnings


Skin Cancer/Skin Aging Alert:

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • children under 6 months: Ask a doctor

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

  • protect this product from excesive heat and direct sun

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

8

SUNSCREEN LOTION

Broad Spectrum SPF 8

Water Resistant

(80 Minutes)

CLEANTOUCH

TECHNOLOGY

133 mL / 4.5 Fl Oz

CALIFORNIA TAN  BROAD SPECTRUM SPF 8
avobenzone, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0082
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE4.9 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE19.6 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE14.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
3-BUTYLPHTHALIDE (UNII: 822Q956KGM)  
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
POLYSILICONE-15 (UNII: F8DRP5BB29)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
STYRENE (UNII: 44LJ2U959V)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
MAGNESIUM (UNII: I38ZP9992A)  
AMINO ACIDS (UNII: 0O72R8RF8A)  
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
SOY PROTEIN (UNII: R44IWB3RN5)  
CALCIUM (UNII: SY7Q814VUP)  
ZINC (UNII: J41CSQ7QDS)  
PLECTRANTHUS BARBATUS WHOLE (UNII: Q86533SAQ7)  
DEXTROSE (UNII: IY9XDZ35W2)  
ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N)  
PYRUVIC ACID (UNII: 8558G7RUTR)  
ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0082-3133 mL in 1 TUBE; Type 0: Not a Combination Product12/09/201312/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/09/201312/31/2018
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028label(58443-0082) , pack(58443-0082) , manufacture(58443-0082) , analysis(58443-0082)

Revised: 3/2022
Document Id: db10c67c-1990-5f1d-e053-2a95a90a0020
Set id: eac90a17-b7b3-4ef1-84b5-f3a4ffe11ac7
Version: 4
Effective Time: 20220325
 
Prime Enterprises, Inc.