CALIFORNIA TAN CONTINUOUS SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray 
Prime Packaging 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 Continuous Sunscreen Broad Spectrum SPF 30

Active Ingredients

Avobenzone 2%

Homosalate 7.5%

Octisalate 5%

Octocrylene 2.75%

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. Keep away from face to avoid breathing it

Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F

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.

Flammable: Do not use near heat, flame or while smoking.

Directions

Adenosine Cyclic Phosphate, Adenosine Triphosphate, Camellia Sinensis (Green Tea) Leaf Extract, Coleus Forskohlii Extract, Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Glucose, Hydrolyzed Soy Protein, Lycium Barbarum (Goji Berry) Fruit Extract, Micrococcus Lysate, Phospholipids, Plant Amino Acids, Polyester-8, Polyperfluoroethoxymethoxy Difluorohydroxyethyl PEG Phosphate, Propylene Glycol, Pyruvic Acid, Saccharomyces Calcium Ferment, Saccharomyces Lysate Extract, Saccharomyces Magnesium Ferment, Saccharomyces Zinc Ferment, Alcohol Denat., VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water (Aqua)

Other Information

Question or comments?

Call toll free 1-800 SUNCARE

California Tan Contiuous Sunscreen Broad Spectrum SPF 30

Principal Display Image

CALIFORNIA TAN  CONTINUOUS SUNSCREEN BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE16.5 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE62 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE41.3 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE22.7 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE16.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)  
ALCOHOL (UNII: 3K9958V90M)  
ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
PLECTRANTHUS BARBATUS ROOT (UNII: V5741391RG)  
AMINO ACIDS (UNII: 0O72R8RF8A)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
DEXTROSE (UNII: IY9XDZ35W2)  
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
WATER (UNII: 059QF0KO0R)  
PYRUVIC ACID (UNII: 8558G7RUTR)  
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
DIBUTYL MALEATE (UNII: 4X371TMK9K)  
MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0112-4150 mL in 1 CAN; Type 0: Not a Combination Product12/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/30/2015
Labeler - Prime Packaging Inc. (805987059)
Registrant - Prime Packaging Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc101946028manufacture(13630-0112) , analysis(13630-0112)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging Inc.805987059pack(13630-0112) , label(13630-0112)

Revised: 1/2020
Document Id: 9c5c4c92-d547-fead-e053-2a95a90a2762
Set id: 37867c19-8fd2-337e-e054-00144ff88e88
Version: 2
Effective Time: 20200117
 
Prime Packaging Inc.