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

Active ingredients

Avobenzone 1 %, Octocrylene 2.75 %, and Oxybenzone 1 %

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. 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

  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly into face. Spray on hands then apply to face
  • do not apply in windy conditions
  • use in well-ventilated areas.
  • 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

Adenosine Cyclic Phosphate, Adenosine Triphosphate, C12-15 Alkyl Benzoate, 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

  • protect this product from excesive heat and direct sun
  • avoid spraying on fabrics - could cause discoloration

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 8

SUNSCREEN SPRAY

Broad Spectrum SPF 8

Water Resistant

(80 Minutes)

OIL FREE

150 mL/5 Fl Oz

CALIFORNIA TAN  BROAD SPECTRUM SPF 8
avobenzone, octocrylene and oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0061
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE8.1 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE22.2 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE8.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ALCOHOL (UNII: 3K9958V90M)  
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
PYRUVIC ACID (UNII: 8558G7RUTR)  
DEXTROSE (UNII: IY9XDZ35W2)  
ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N)  
ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)  
DIBUTYL MALEATE (UNII: 4X371TMK9K)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0061-3150 mL in 1 CAN; Type 0: Not a Combination Product11/28/201112/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/28/201112/31/2018
Labeler - Prime Packaging, Inc. (805987059)
Registrant - Prime Packaging, Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(13630-0061) , analysis(13630-0061)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging, Inc.805987059label(13630-0061) , pack(13630-0061)

Revised: 4/2022
Document Id: dbdaf520-a55a-9863-e053-2a95a90aba87
Set id: ded804a6-f3de-4ea0-8141-08e304ff3a8a
Version: 4
Effective Time: 20220404
 
Prime Packaging, Inc.