Label: CALIFORNIA TAN CONTINUOUS SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray
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Contains inactivated NDC Code(s)
NDC Code(s): 13630-0112-4 - 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Warnings
For external use only
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°F
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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 a well-ventilated area
- reapply:
- after 80 minutes of swimming and 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
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INACTIVE INGREDIENT
Adenosine Cyclic Phosphate, Adenosine Triphosphate, Camellia Sinensis (Green Tea) Leaf Extract, Coleus 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
- Question or comments?
- California Tan Contiuous Sunscreen Broad Spectrum SPF 30
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INGREDIENTS AND APPEARANCE
CALIFORNIA TAN CONTINUOUS SUNSCREEN BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0112 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 16.5 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 62 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 41.3 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 22.7 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 16.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE) ALCOHOL (UNII: 3K9958V90M) ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6) PLECTRANTHUS BARBATUS ROOT (UNII: V5741391RG) AMINO ACIDS (UNII: 0O72R8RF8A) GREEN TEA LEAF (UNII: W2ZU1RY8B0) DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM) DEXTROSE (UNII: IY9XDZ35W2) LYCIUM BARBARUM FRUIT (UNII: 930626MWDL) WATER (UNII: 059QF0KO0R) PYRUVIC ACID (UNII: 8558G7RUTR) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) DIBUTYL MALEATE (UNII: 4X371TMK9K) MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0112-4 150 mL in 1 CAN; Type 0: Not a Combination Product 12/30/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/30/2015 Labeler - Prime Packaging Inc. (805987059) Registrant - Prime Packaging Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc 101946028 manufacture(13630-0112) , analysis(13630-0112) Establishment Name Address ID/FEI Business Operations Prime Packaging Inc. 805987059 pack(13630-0112) , label(13630-0112)
