CALIFORNIA TAN SPF 45 FACE SUNSCREEN- avobenzone, homosalate, octisalate, and octocrylene aerosol, foam

California Tan by

Drug Labeling and Warnings

California Tan by is a Otc medication manufactured, distributed, or labeled by Prime Packaging, Inc., Prime Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3 %, Homosalate 15%, Octisalate 5 %, and Octocrylene 2.75 %

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if use as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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

• apply liberally and spread evenly by hand 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m - 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

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

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

Questions or comments?

Call toll free 1-800-SUNCARE

PRINCIPAL DISPLAY PANEL - 142 g 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)

INGREDIENTS AND APPEARANCE

CALIFORNIA TAN  SPF 45 FACE SUNSCREEN
avobenzone, homosalate, octisalate, and octocrylene aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0078
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	300 g  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	1500 g  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	500 g  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	275 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
(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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0078-4	142 g in 1 CAN; Type 0: Not a Combination Product	12/30/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/30/2013

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	manufacture(13630-0078) , analysis(13630-0078)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging, Inc.		805987059	label(13630-0078) , pack(13630-0078)