Indications and uses
helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
California Tan
- Manufacturer
- Prime Enterprises, Inc.
- Effective date
- 2020-01-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 23:03:10
Label at a glance#
ProductCalifornia Tan BROAD SPECTRUM SPF 45
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure9 sections
Dosage and administration
apply liberally 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 e...
Label contents#
Full prescribing information#
Active ingredients
Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.7 %, and Oxybenzone 2 %
OTC - PURPOSE SECTION
Purpose
Sunscreen
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Warnings
OTHER SAFETY INFORMATION
For external use only
OTC - DO NOT USE SECTION
Do not use on damaged or broken skin.
OTC - WHEN USING SECTION
When using this product keep out of eyes. Rinse with water to remove.
OTC - STOP USE SECTION
Stop use and ask a doctor if rash occurs.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
OTHER SAFETY INFORMATION
Directions
- apply liberally 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/C10-30 Alkyl Acrylate Crosspolymer, Adenosine Cyclic Phosphate, Adenosine Triphosphate, Butylated Hydroxytoluene, Butylphthalimide, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Coelus Forskohlii Extract, Disodium EDTA, Fragrance (Parfum), Glucose, Hydrolyzed Soy Protein, Isopropylphthalimide, Lycium Barbarum (Goji Berry) Fruit Extract, Methylisothiazolinone, Methylparaben, Micrococcus Lysate, Phenyl Trimethicone, Phospholipids, Plant Amino Acids, Polyethylene, Polyperfluoroethoxymethoxy Difluorohydroxyethyl PEG Phosphate, Polysilicone-15, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Propylparaben, Pyruvic Acid, Saccharomyces Calcium Ferment, Saccharomyces Lysate Extract, Saccharomyces Magnesium Ferment, Saccharomyces Zinc Ferment, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Water (Aqua)
Other information
- protect this product from excesive heat and direct sun
OTC - QUESTIONS SECTION
Questions or Comments?
Call toll free 1-800-SUNCARE
PRINCIPAL DISPLAY PANEL - 133 mL Tube Label
CALIFORNIA TAN
CT
45
SUNSCREEN LOTION
Broad Spectrum SPF 45
Water Resistant
(80 Minutes)
CLEANTOUCH
TECHNOLOGY
133 mL / 4.5 Fl Oz
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ef9a935e-31b7-402c-a66c-716cdfe4f126 | Product name | 9 | 20241218 |
| 115c5bd2-98e1-4a98-8292-90803ca7e851 | Product name | 1 | 20220127 |
| ed912195-5da0-0f2f-6f4b-3ef17710cbe3 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58443-0097-3 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3974-111a-e063-dadaa90a10e2 | 8ea7a7d5-4c8b-402f-91a3-165567a484e4 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58443-0097-3 | California TanBROAD SPECTRUM SPF 45 | 133 mL in 1 TUBE | LOTION | 133 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58443-0097 | CALIFORNIA TAN BROAD SPECTRUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] | 4 | Legacy NDC, 1 package rows | 20200118_8ea7a7d5-4c8b-402f-91a3-165567a484e4.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| AVOBENZONE | ACTIVE INGREDIENT | G63QQF2NOX | 1 | |
| HOMOSALATE | ACTIVE INGREDIENT | V06SV4M95S | 1 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| OCTOCRYLENE | ACTIVE INGREDIENT | 5A68WGF6WM | 1 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| AVOBENZONE | ACTIVE MOIETY | G63QQF2NOX | 1 | |
| HOMOSALATE | ACTIVE MOIETY | V06SV4M95S | 1 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| OCTOCRYLENE | ACTIVE MOIETY | 5A68WGF6WM | 1 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| 3-BUTYLPHTHALIDE | INACTIVE INGREDIENT | 822Q956KGM | 1 | |
| ADENOSINE CYCLIC PHOSPHATE | INACTIVE INGREDIENT | E0399OZS9N | 1 | |
| ADENOSINE TRIPHOSPHATE | INACTIVE INGREDIENT | 8L70Q75FXE | 1 | |
| AMINO ACIDS | INACTIVE INGREDIENT | 0O72R8RF8A | 1 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| CALCIUM | INACTIVE INGREDIENT | SY7Q814VUP | 1 | |
| CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) | INACTIVE INGREDIENT | 71DD5V995L | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| DEXTROSE | INACTIVE INGREDIENT | IY9XDZ35W2 | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| GREEN TEA LEAF | INACTIVE INGREDIENT | W2ZU1RY8B0 | 1 | |
| HIGH DENSITY POLYETHYLENE | INACTIVE INGREDIENT | UG00KM4WR7 | 1 | |
| ISOPROPYLPHTHALIMIDE | INACTIVE INGREDIENT | 1J1MM83329 | 1 | |
| LYCIUM BARBARUM FRUIT | INACTIVE INGREDIENT | 930626MWDL | 1 | |
| MAGNESIUM | INACTIVE INGREDIENT | I38ZP9992A | 1 | |
| METHYLISOTHIAZOLINONE | INACTIVE INGREDIENT | 229D0E1QFA | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| OMEGA-3 FATTY ACIDS | INACTIVE INGREDIENT | 71M78END5S | 1 | |
| PHENYL TRIMETHICONE | INACTIVE INGREDIENT | DR0K5NOJ4R | 1 | |
| PLECTRANTHUS BARBATUS ROOT | INACTIVE INGREDIENT | V5741391RG | 1 | |
| POLYSILICONE-15 | INACTIVE INGREDIENT | F8DRP5BB29 | 1 | |
| POTASSIUM CETYL PHOSPHATE | INACTIVE INGREDIENT | 03KCY6P7UT | 1 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| PYRUVIC ACID | INACTIVE INGREDIENT | 8558G7RUTR | 1 | |
| SACCHAROMYCES LYSATE | INACTIVE INGREDIENT | R85W246Z1C | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SOY PROTEIN | INACTIVE INGREDIENT | R44IWB3RN5 | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | 1 | |
| STYRENE | INACTIVE INGREDIENT | 44LJ2U959V | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| ZINC | INACTIVE INGREDIENT | J41CSQ7QDS | 1 |
Products#
Every source-derived product name is available through these pages.
- California Tan BROAD SPECTRUM SPF 45
- Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
- POLYSILICONE-15
- POTASSIUM CETYL PHOSPHATE
- POTASSIUM HYDROXIDE
- PROPYLENE GLYCOL
- PROPYLPARABEN
- PYRUVIC ACID
- CALCIUM
- SACCHAROMYCES LYSATE
- MAGNESIUM
- ZINC
- SILICON DIOXIDE
- STEARYL ALCOHOL
- STYRENE
- WATER
- AVOBENZONE
- HOMOSALATE
- OCTISALATE
- OCTOCRYLENE
- OXYBENZONE
- CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
- ADENOSINE CYCLIC PHOSPHATE
- ADENOSINE TRIPHOSPHATE
- BUTYLATED HYDROXYTOLUENE
- 3-BUTYLPHTHALIDE
- GREEN TEA LEAF
- CETYL ALCOHOL
- PLECTRANTHUS BARBATUS ROOT
- EDETATE DISODIUM
- DEXTROSE
- SOY PROTEIN
- ISOPROPYLPHTHALIMIDE
- LYCIUM BARBARUM FRUIT
- METHYLISOTHIAZOLINONE
- METHYLPARABEN
- PHENYL TRIMETHICONE
- HIGH DENSITY POLYETHYLENE
- OMEGA-3 FATTY ACIDS
- AMINO ACIDS
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58443-0097 | 58443-0097-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY, METERED / NASAL | 4 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.16 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | FILM, SOLUBLE / ORAL | 0.06 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| POTASSIUM HYDROXIDE | POTASSIUM HYDROXIDE | WZH3C48M4T | GEL / TOPICAL | 3 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION, CONCENTRATE / ORAL | 1 mg/1ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SOLUTION / ORAL | 336 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SUBCUTANEOUS | 22 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE / ORAL | 3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LIQUID / ORAL | 162 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | POWDER / VAGINAL | 430 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | INJECTION, SOLUTION / INTRATHECAL | 1925 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SOAP / TOPICAL | 0.02 %w/w | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | TABLET, COATED / ORAL | 132 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM / VAGINAL | 3 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | ELIXIR / ORAL | 1.3 mg/5ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / AURICULAR (OTIC) | NA | ||
| CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) | 71DD5V995L | LOTION / TOPICAL | 21 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / AURICULAR (OTIC) | 0.01 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM / TOPICAL | 14 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, COATED / ORAL | 16 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SWAB / TOPICAL | 34.6 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / SUBCUTANEOUS | 1.4 %w/v | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | CAPSULE, EXTENDED RELEASE / ORAL | 72 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / DENTAL | 19 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LOTION / TOPICAL | 351 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / NASAL | 5 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / INTRAMUSCULAR | 4 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, EXTENDED RELEASE / ORAL | 132 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / SUBCUTANEOUS | 6 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LOTION / TOPICAL | 22 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAMUSCULAR | 7459 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / TOPICAL | 6 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 15 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / VAGINAL | 3 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | TABLET, EXTENDED RELEASE / ORAL | 103.95 mg | ||
| POTASSIUM HYDROXIDE | POTASSIUM HYDROXIDE | WZH3C48M4T | SOLUTION / TOPICAL | 14.02 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET / ORAL | 100 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET, EXTENDED RELEASE / ORAL | 0.12 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | JELLY / NASAL | 140 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / TOPICAL | 0.8 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | DROPS / NASAL | 14 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION/ DROPS / OPHTHALMIC | 0.01 %w/v |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 9c59712e-ed48-fa1c-e053-2995a90a0223 | 8ea7a7d5-4c8b-402f-91a3-165567a484e4 | 2020-01-17 | Warnings | 9c59712e-ed48-fa1c-e053-2995a90a0223 8ea7a7d5-4c8b-402f-91a3-165567a484e4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.