Label: CALIFORNIA TAN BROAD SPECTRUM SPF 15- avobenzone, octisalate and octocrylene spray
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Contains inactivated NDC Code(s)
NDC Code(s): 13630-0064-3 - Packager: Prime Packaging, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 17, 2020
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- Official Label (Printer Friendly)
- Active ingredients
- PURPOSE
- Uses
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Warnings
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
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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 area
- reapply
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
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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
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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
- PRINCIPAL DISPLAY PANEL - 150 mL Can Label
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INGREDIENTS AND APPEARANCE
CALIFORNIA TAN BROAD SPECTRUM SPF 15
avobenzone, octisalate and octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0064 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 16 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 40.3 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 22.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0064-3 150 mL in 1 CAN; Type 0: Not a Combination Product 12/28/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/28/2011 Labeler - Prime Packaging, Inc. (805987059) Registrant - Prime Packaging, Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 manufacture(13630-0064) , analysis(13630-0064) Establishment Name Address ID/FEI Business Operations Prime Packaging, Inc. 805987059 label(13630-0064) , pack(13630-0064)
