CALIFORNIA TAN SPF 45 FACE SUNSCREEN- avobenzone, homosalate, octisalate, and octocrylene aerosol, foam 
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 3 %, Homosalate 15%, 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. 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.

Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Directions

Inactive Ingredients

Acrylates/C12-22 Alkyl Methacrylate Cocolymer, Adenosine Cyclic Phesphate, Adenosine Triphosphate, Allantoin, Aloe Barbadensis Leaf Juice, Butane, Butylene Glycol, Camelllia Sinensis (Green Tea) Leaf Extract, Ceteareth-20, Cetearyl Alcohol, Chamomilla Recitita (Matricaria) Flower Extract, Coleus Forskohlii Root Extract, Disodium EDTA, EDTA, Glucose, Hydrolyzed Soy Protein, Isostearic Acid, Lycium Barbarum (Goji Berry) Fruit Extract, Methylisothiazolinone, Methylparaben, Micrococcus Lysate, Phenoxyethanol, Phenyl Trimethicone, Phospholipids, Plant Amino Acids, Polyperfluoroethoxymethoxy Difluoroethyl PEG Phosphate, Polysorbate 20, Polysorbate 60, Propane, Propylene Glycol, Pyruvic Acid, Quaternium-15, Saccharomyces/Calcium Ferment, Saccharomyces Lysate Extract, Saccharomyces/Magnesium Ferment, Saccharomyces/Zinc Ferment, Sodium Polyacrylate, Stearic Acid, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

Other Information

Questions or comments?

Call toll free 1-800-SUNCARE

PRINCIPAL DISPLAY PANEL - 142 g Can Label

PRINCIPAL DISPLAY PANEL - 142g Can Label

California Tan

CT

45

Face

Mousse

Sunscreen Mousse

Broad Spectrum SPF 45

Water Resistant

(80 Minutes)

OIL FREE • FRAGRANCE-FREE

Net Wt. 5 oz (142g)

CALIFORNIA TAN  SPF 45 FACE SUNSCREEN
avobenzone, homosalate, octisalate, and octocrylene aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0078
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE300 g  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE1500 g  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE500 g  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE275 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTANE (UNII: 6LV4FOR43R)  
PROPANE (UNII: T75W9911L6)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETEARETH-22 (UNII: 28VZG1E234)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
AMINO ACIDS (UNII: 0O72R8RF8A)  
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
SOY PROTEIN (UNII: R44IWB3RN5)  
CALCIUM (UNII: SY7Q814VUP)  
MAGNESIUM (UNII: I38ZP9992A)  
ZINC (UNII: J41CSQ7QDS)  
COLEUS FORSKOHLII ROOT OIL (UNII: 5NXR7DJ9WO)  
CATALASE (MICROCOCCUS LUTEUS) (UNII: 7TXA8K9WAE)  
DEXTROSE (UNII: IY9XDZ35W2)  
ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N)  
PYRUVIC ACID (UNII: 8558G7RUTR)  
ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)  
QUATERNIUM-15 (UNII: E40U03LEM0)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0078-4142 g in 1 CAN; Type 0: Not a Combination Product12/30/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/30/2013
Labeler - Prime Packaging, Inc. (805987059)
Registrant - Prime Packaging, Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(13630-0078) , analysis(13630-0078)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging, Inc.805987059label(13630-0078) , pack(13630-0078)

Revised: 12/2018
Document Id: 7d669cff-0fe8-a509-e053-2a91aa0aadae
Set id: 09f29dfc-de81-40f1-ad17-56ee4efca509
Version: 2
Effective Time: 20181219
 
Prime Packaging, Inc.