CALIFORNIA TAN BROAD SPECTRUM SPF 15- avobenzone, octisalate and octocrylene 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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Active ingredients

Avobenzone 2 %, Octisalate 5 %, and Octocrylene 2.75 %

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 0F

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

Inactive Ingredients

Adenosine Cyclic Phosphate, Adenosine Triphosphate, Camellia Sinensis (Green Tea) Leaf Extract, Coelus 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

Questions or Comments?
Call toll free 1-800-SUNCARE

PRINCIPAL DISPLAY PANEL - 150 mL Can Label

PRINCIPAL DISPLAY PANEL - 150 mL Can Label

CALIFORNIA TAN

CT 15

SUNSCREEN SPRAY

Broad Spectrum SPF 15

Water Resistant

(80 Minutes)

OIL FREE

150 mL/ 5 Fl Oz

CALIFORNIA TAN  BROAD SPECTRUM SPF 15
avobenzone, octisalate and octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0064
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE16 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40.3 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE22.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ALCOHOL (UNII: 3K9958V90M)  
ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)  
PYRUVIC ACID (UNII: 8558G7RUTR)  
ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N)  
DEXTROSE (UNII: IY9XDZ35W2)  
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
DIBUTYL MALEATE (UNII: 4X371TMK9K)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0064-3150 mL in 1 CAN; Type 0: Not a Combination Product12/28/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/28/2011
Labeler - Prime Packaging, Inc. (805987059)
Registrant - Prime Packaging, Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(13630-0064) , analysis(13630-0064)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging, Inc.805987059label(13630-0064) , pack(13630-0064)

Revised: 1/2020
Document Id: 9c5c40dc-b158-a925-e053-2a95a90a8f7b
Set id: 88a37b3e-3e17-4c7e-be72-980769694d54
Version: 3
Effective Time: 20200117
 
Prime Packaging, Inc.