Label: CALIFORNIA TAN SPF 30 BROAD SPECTRUM SUNSCREEN- avobenzone, homosalate, octisalate, and octocrylene aerosol, foam
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Contains inactivated NDC Code(s)
NDC Code(s): 13630-0079-4 - 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 December 19, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
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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
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Inactive Ingredients
Adenosine Cyclic Phesphate, Adenosine Triphosphate, Aloe Barbadensis Leaf Juice, Camelllia Sinensis (Green Tea) Leaf Extract, Ceteareth-20, Cetearyl Alcohol, Coleus Forskohlii Root Extract, Disodium EDTA, EDTA, Fragrance (Parfum), 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, VP/Hexadecene, Water (Aqua)
- Other Information
- PRINCIPAL DISPLAY PANEL - 170 g Can Label
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INGREDIENTS AND APPEARANCE
CALIFORNIA TAN SPF 30 BROAD SPECTRUM SUNSCREEN
avobenzone, homosalate, octisalate, and octocrylene aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0079 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 1000 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTANE (UNII: 6LV4FOR43R) PROPANE (UNII: T75W9911L6) 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) 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) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) 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:13630-0079-4 170 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(13630-0079) , analysis(13630-0079) Establishment Name Address ID/FEI Business Operations Prime Packaging, Inc. 805987059 label(13630-0079) , pack(13630-0079)
