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
UV Defense Fluid
- Manufacturer
- H2O Plus
- Effective date
- 2014-04-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:38:59
Label at a glance#
ProductUV Defense Fluid
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure10 sections
Dosage and administration
apply generously and evenly 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating 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 value of 15 or higher and other sun protection measures including: limit time in the sun, ...
Storage and handling
protect the product in this container from excessive heat and direct sun
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredient | Purpose |
|---|---|
| Zinc Oxide 14% | Sunscreen |
| Titanium Dioxide 11% | 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
- For external use only
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 skin rash occurs
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- apply generously and evenly 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
- 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 value 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-sleeved shirts, pants, hats, and sunglasses
Inactive ingredients
Cyclopentasiloxane, Aqua/Water/Eau, Dimethicone, Acrylates/Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Dipropylene Glycol, Isodecyl Isononanoate, Alumina, Stearic Acid, C12-15 Alkyl Benzoate, Sodium Chloride, Aspalathus Linearis Extract, Camellia Sinensis Leaf Extract, Phyllanthus Emblica Fruit Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Undaria Pinnatifida Extract, Tocopherol, Caprylyl Glycol, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipotassium Glycyrrhizate, Ferulic Acid, Glycerin, Glyceryl Polyacrylate, Hydrogen Dimethicone, Hydrolyzed Pearl, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Maltodextrin, PEG/PPG18/18 Dimethicone, Propylene Glycol, Sodium Citrate, Sodium Hyaluronate, Tetrahydrodiferuloylmethane, Phenoxyethanol, Potassium Sorbate, Sorbic Acid, Parfum/ Fragrance, Benzyl Salicylate, Hexyl Cinnamal, Limonene, Linalool, CI 77491/ Iron Oxides, CI 77492/Iron Oxides (090-20171-000)
Other information
- protect the product in this container from excessive heat and direct sun
Questions or comments?
1-800-242-2284
SPL UNCLASSIFIED SECTION
Distributed by:
H2O Plus, L.L.C.
Chicago, IL 60607
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
h2o+™
total SOURCE™
Advanced age repair
UV DEFENSE FLUID
SPF 50 PA+++
30 mL / 1 U.S. Fl oz e
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65903-171-01 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-48ae-60a7-e053-dbdaa90a05bd | UV Defense Fluid |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65903-171-01 | UV Defense Fluid | 30 mL in 1 BOTTLE, WITH APPLICATOR | CREAM | 30 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Titanium Dioxide | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| Zinc Oxide | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| Titanium Dioxide | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| Zinc Oxide | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| .Alpha.-Hexylcinnamaldehyde | INACTIVE INGREDIENT | 7X6O37OK2I | 1 | |
| Alkyl (C12-15) Benzoate | INACTIVE INGREDIENT | A9EJ3J61HQ | 1 | |
| Aluminum Oxide | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| Benzyl Benzoate | INACTIVE INGREDIENT | N863NB338G | 1 | |
| Calcium Carbonate | INACTIVE INGREDIENT | H0G9379FGK | 1 | |
| Caprylyl Glycol | INACTIVE INGREDIENT | 00YIU5438U | 1 | |
| Cyclomethicone 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| Dimethicone | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| Dimethicone/Vinyl Dimethicone Crosspolymer (Hard Particle) | INACTIVE INGREDIENT | H895X08VNQ | 1 | |
| Dipropylene Glycol | INACTIVE INGREDIENT | E107L85C40 | 1 | |
| Ferric Oxide Red | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| Ferulic Acid | INACTIVE INGREDIENT | AVM951ZWST | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Glycyrrhizinate Dipotassium | INACTIVE INGREDIENT | CA2Y0FE3FX | 1 | |
| Green Tea Leaf | INACTIVE INGREDIENT | W2ZU1RY8B0 | 1 | |
| Hyaluronate Sodium | INACTIVE INGREDIENT | YSE9PPT4TH | 1 | |
| Isodecyl Isononanoate | INACTIVE INGREDIENT | 4X46Q4U00Z | 1 | |
| Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone | INACTIVE INGREDIENT | 25G622K2RA | 1 | |
| Limonene, (-)- | INACTIVE INGREDIENT | 47MAJ1Y2NE | 1 | |
| Linalool, (+/-)- | INACTIVE INGREDIENT | D81QY6I88E | 1 | |
| Maltodextrin | INACTIVE INGREDIENT | 7CVR7L4A2D | 1 | |
| PEG/PPG-18/18 Dimethicone | INACTIVE INGREDIENT | 9H0AO7T794 | 1 | |
| Phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| Phyllanthus Emblica Fruit | INACTIVE INGREDIENT | YLX4CW2576 | 1 | |
| Potassium Sorbate | INACTIVE INGREDIENT | 1VPU26JZZ4 | 1 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| Rosemary | INACTIVE INGREDIENT | IJ67X351P9 | 1 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| Sodium Citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| Sorbic Acid | INACTIVE INGREDIENT | X045WJ989B | 1 | |
| Stearic Acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| Tetrahydrodiferuloylmethane | INACTIVE INGREDIENT | 00U0645U03 | 1 | |
| Tocopherol | INACTIVE INGREDIENT | R0ZB2556P8 | 1 | |
| Undaria Pinnatifida | INACTIVE INGREDIENT | ICV1OK7M1S | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- UV Defense Fluid
- Titanium Dioxide and Zinc Oxide
- Titanium Dioxide
- Zinc Oxide
- Aluminum Oxide
- Water
- Alkyl (C12-15) Benzoate
- Green Tea Leaf
- Caprylyl Glycol
- Cyclomethicone 5
- Dimethicone
- Dimethicone/Vinyl Dimethicone Crosspolymer (Hard Particle)
- Glycyrrhizinate Dipotassium
- Dipropylene Glycol
- Ferulic Acid
- Glycerin
- Calcium Carbonate
- Ferric Oxide Red
- Isodecyl Isononanoate
- Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone
- Maltodextrin
- PEG/PPG-18/18 Dimethicone
- Phenoxyethanol
- Phyllanthus Emblica Fruit
- Potassium Sorbate
- Propylene Glycol
- Rosemary
- Sodium Chloride
- Sodium Citrate
- Hyaluronate Sodium
- Sorbic Acid
- Stearic Acid
- Tetrahydrodiferuloylmethane
- Tocopherol
- Undaria Pinnatifida
- Benzyl Benzoate
- .Alpha.-Hexylcinnamaldehyde
- Limonene, (-)-
- Linalool, (+/-)-
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 65903-171 | 65903-171-01 |
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 |
|---|---|---|---|---|---|---|
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | JELLY / TOPICAL | 20 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, COATED / ORAL | 16 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| Cyclomethicone 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | AEROSOL / TOPICAL | 2.5 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPONGE / TOPICAL | 40 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION/ DROPS / TOPICAL | 0.23 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 24 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / OPHTHALMIC | 10 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION/ DROPS / OPHTHALMIC | 55 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / NASAL | 5 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAVENOUS | 90 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / IONTOPHORESIS | 0.6 %w/v | ||
| Sorbic Acid | SORBIC ACID | X045WJ989B | CONCENTRATE / ORAL | 1 mg | ||
| Hyaluronate Sodium | HYALURONATE SODIUM | YSE9PPT4TH | INJECTION, SUSPENSION / INTRAMUSCULAR | 23 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO, SUSPENSION / TOPICAL | 2 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4886 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | GEL / OPHTHALMIC | 0.9 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TRANSDERMAL | 500 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 0.15 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRALESIONAL | 0.9 %w/v | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, DELAYED RELEASE / ORAL | 37 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | DROPS / OPHTHALMIC | 0.08 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAMUSCULAR | 1486 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| Potassium Sorbate | POTASSIUM SORBATE | 1VPU26JZZ4 | SPRAY, METERED / NASAL | 0.06 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / AURICULAR (OTIC) | 0.9 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION, AUGMENTED / TOPICAL | 2070 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE / ORAL | 5 mg | ||
| Maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | GRANULE, FOR SUSPENSION / ORAL | 952 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 0.68 %w/v | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / SOFT TISSUE | 26 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 226 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | DROPS / ORAL | 200 mg/1ml | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION/ DROPS / TOPICAL | 0.86 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / AURICULAR (OTIC) | 56.55 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| Ferric Oxide Red | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, EXTENDED RELEASE / ORAL | 5 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SYSTEM / TOPICAL | 3.1 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / RECTAL | 90400 mg | ||
| Dipropylene Glycol | DIPROPYLENE GLYCOL | E107L85C40 | FILM, EXTENDED RELEASE / TRANSDERMAL | 296 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / ENDOTRACHEAL | 7.6 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL | 226 mg | ||
| Maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | FILM, SOLUBLE / ORAL | 19 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / OPHTHALMIC | 0.6 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg |
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 |
|---|---|---|---|---|---|---|
| 8b291140-d4a3-4952-a404-1c0b008e3b2b | 7062d96c-3b39-4d21-a2ae-7a8d9df3c96a | 2014-04-14 | Warnings | 8b291140-d4a3-4952-a404-1c0b008e3b2b 7062d96c-3b39-4d21-a2ae-7a8d9df3c96a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.