OTC - ACTIVE INGREDIENT SECTION
Active Ingredient:
Zinc Oxide 13.5%
Ultra UV Defense SPF 30
- Manufacturer
- Jenelt Cosmetics | CoValence Laboratories
- Effective date
- 2015-11-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:44:02
Label at a glance#
ProductUltra UV Defense SPF 30
Active ingredientZINC OXIDE
Label structure9 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Purpose: Sunscreen
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.
INDICATIONS & USAGE SECTION
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 SECTION
Warnings:
- For external use only.
- Do not use on damaged or broken skin.
- When using this product keep out of eyes. Rinse with water to remove.
- Stop use and ask a doctor if rash occurs.
- Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions:
- Apply liberally 15 minutes before sun exposure.
- Use a water resistant sunscreen if swimming or sweating.
- Reapply 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 INGREDIENT SECTION
Inactive Ingredients: Aqua (Water), Caprylic/Capric Triglyceride, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Glycerin, Isodecyl Neopentanoate, Ethyl Macadamiate, Aleurites Moluccana Seed Oil, Hydroxypropyl Starch Phosphate, Glyceral Stearate, Hamamelis Virginiana (Witch Hazel) Water, Ergothioneine (L), Hordeum Distichon (Barley) Extract, Macadamia Ternifolia Seed Oil, Porphyra Umbilicalis (Red Algae) Extract, Santalum Album (Sandalwood) Extract, Phellodendron Amurense Bark Extract, Glyceryl Isostearate, Sodium Stearoyl Lactylate, Polyglyceryl-10 Pentastearate, Polyhydroxystearic Acid, Tocopheryl Acetate (D-alpha), Tocopherol (D-alpha), Lecithin, Malic Acid (L) Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Alcohol, Cetearyl Alcohol, Behenyl Alchohol, Hydroxypropyl Methylcellulose, Sodium Lactate, Phytic Acid, Citric Acid, Sodium Hydroxide
OTHER SAFETY INFORMATION
Other Information:
- Protect this product from excessive heat and direct sun.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| 597b1cfd-7b31-5048-62be-ca5cd740da2f | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58469-6100-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-faf7-f424-e053-dadaa90a57ce | Drug Facts OTC #610; Ultra UV Defense SPF 30 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58469-6100-1 | Ultra UV Defense SPF 30 | 60 g in 1 TUBE | CREAM | 60 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58469-6100 | ULTRA UV DEFENSE SPF 30 (ZINC OXIDE) CREAM [JENELT COSMETICS] | 1 | Legacy NDC, 1 package rows | 20151112_244b582b-3509-382e-e054-00144ff8d46c.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE, D- | INACTIVE INGREDIENT | A7E6112E4N | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| BARLEY | INACTIVE INGREDIENT | 5PWM7YLI7R | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| DOCOSANOL | INACTIVE INGREDIENT | 9G1OE216XY | 1 | |
| EGG PHOSPHOLIPIDS | INACTIVE INGREDIENT | 1Z74184RGV | 1 | |
| ERGOTHIONEINE | INACTIVE INGREDIENT | BDZ3DQM98W | 1 | |
| ETHYL MACADAMIATE | INACTIVE INGREDIENT | ANA2NCS6V1 | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GLYCERYL ISOSTEARATE | INACTIVE INGREDIENT | HYE7O27HAO | 1 | |
| HAMAMELIS VIRGINIANA LEAF WATER | INACTIVE INGREDIENT | 8FP93ED6H2 | 1 | |
| HYDROGENATED PALM GLYCERIDES | INACTIVE INGREDIENT | YCZ8EM144Q | 1 | |
| HYPROMELLOSE 2208 (100 MPA.S) | INACTIVE INGREDIENT | B1QE5P712K | 1 | |
| ISODECYL NEOPENTANOATE | INACTIVE INGREDIENT | W60VYE24XC | 1 | |
| KUKUI NUT OIL | INACTIVE INGREDIENT | TP11QR7B8R | 1 | |
| LONICERA CAPRIFOLIUM FLOWER | INACTIVE INGREDIENT | 5N1WD9784U | 1 | |
| LONICERA JAPONICA FLOWER | INACTIVE INGREDIENT | 4465L2WS4Y | 1 | |
| MACADAMIA OIL | INACTIVE INGREDIENT | 515610SU8C | 1 | |
| MALIC ACID | INACTIVE INGREDIENT | 817L1N4CKP | 1 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | 1 | |
| PHELLODENDRON AMURENSE BARK | INACTIVE INGREDIENT | PBG27B754G | 1 | |
| PHYTIC ACID | INACTIVE INGREDIENT | 7IGF0S7R8I | 1 | |
| POLYGLYCERIN-10 | INACTIVE INGREDIENT | P9060O936A | 1 | |
| POLYHYDROXYSTEARIC ACID (2300 MW) | INACTIVE INGREDIENT | YXH47AOU0F | 1 | |
| PORPHYRA UMBILICALIS | INACTIVE INGREDIENT | 14AN0J70WO | 1 | |
| POTASSIUM CETYL PHOSPHATE | INACTIVE INGREDIENT | 03KCY6P7UT | 1 | |
| SANDALWOOD | INACTIVE INGREDIENT | 3641YW25N2 | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| SODIUM LACTATE | INACTIVE INGREDIENT | TU7HW0W0QT | 1 | |
| SODIUM STEAROYL LACTYLATE | INACTIVE INGREDIENT | IN99IT31LN | 1 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Ultra UV Defense SPF 30
- Zinc Oxide
- ISODECYL NEOPENTANOATE
- ETHYL MACADAMIATE
- KUKUI NUT OIL
- HAMAMELIS VIRGINIANA LEAF WATER
- ERGOTHIONEINE
- WATER
- MEDIUM-CHAIN TRIGLYCERIDES
- GLYCERIN
- BARLEY
- MACADAMIA OIL
- PORPHYRA UMBILICALIS
- SANDALWOOD
- PHELLODENDRON AMURENSE BARK
- GLYCERYL ISOSTEARATE
- SODIUM STEAROYL LACTYLATE
- POLYGLYCERIN-10
- POLYHYDROXYSTEARIC ACID (2300 MW)
- .ALPHA.-TOCOPHEROL ACETATE, D-
- TOCOPHEROL
- EGG PHOSPHOLIPIDS
- MALIC ACID
- LONICERA CAPRIFOLIUM FLOWER
- LONICERA JAPONICA FLOWER
- POTASSIUM CETYL PHOSPHATE
- HYDROGENATED PALM GLYCERIDES
- ALCOHOL
- CETOSTEARYL ALCOHOL
- DOCOSANOL
- HYPROMELLOSE 2208 (100 MPA.S)
- SODIUM LACTATE
- PHYTIC ACID
- CITRIC ACID MONOHYDRATE
- SODIUM HYDROXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58469-6100 | 58469-6100-1 |
| 66915-610 |
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 |
|---|---|---|---|---|---|---|
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET / ORAL | 914 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / SUBLINGUAL | 397 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRAVENOUS | ADJ PH | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / TOPICAL | 9971 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / ENDOTRACHEAL | ADJ PH | ||
| MALIC ACID | MALIC ACID | 817L1N4CKP | SOLUTION / ORAL | 16760 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | POWDER, FOR SUSPENSION / ENDOTRACHEAL | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / INTRAMUSCULAR | 26 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / ORAL | 9120 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAMUSCULAR | 176 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | AEROSOL, FOAM / TOPICAL | ADJ PH | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / RESPIRATORY (INHALATION) | 5 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, ORALLY DISINTEGRATING / ORAL | 83 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRACAUDAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / DENTAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | EMULSION / OPHTHALMIC | 0.02 %w/v | ||
| HYPROMELLOSE 2208 (100 MPA.S) | HYPROMELLOSE 2208 (100 MPA.S) | B1QE5P712K | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 360 mg | ||
| HYPROMELLOSE 2208 (100 MPA.S) | HYPROMELLOSE 2208 (100 MPA.S) | B1QE5P712K | CAPSULE, DELAYED RELEASE / ORAL | 630 mg | ||
| HYPROMELLOSE 2208 (100 MPA.S) | HYPROMELLOSE 2208 (100 MPA.S) | B1QE5P712K | LOTION / TOPICAL | 0.1 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | SOLUTION / ORAL | 5566 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | TABLET, COATED / ORAL | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION, CONCENTRATE / INTRAVENOUS | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAVENOUS | 2068 mg | ||
| EGG PHOSPHOLIPIDS | EGG PHOSPHOLIPIDS | 1Z74184RGV | TABLET / ORAL | 48 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | POWDER / INTRAVENOUS | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | EMULSION / ORAL | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / INTRAVENOUS | 0.2 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE, COATED PELLETS / ORAL | 0.01 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAMUSCULAR | 1491 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAOCULAR | 1 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SPRAY / NASAL | ADJ PH | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | LOTION / TOPICAL | 7 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRADISCAL | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / RESPIRATORY (INHALATION) | 8 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| HYPROMELLOSE 2208 (100 MPA.S) | HYPROMELLOSE 2208 (100 MPA.S) | B1QE5P712K | TABLET, EXTENDED RELEASE / ORAL | 1700 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / OPHTHALMIC | 3 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 35.75 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRA-ARTICULAR | ADJ PH | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET, EXTENDED RELEASE / ORAL | 0.37 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / PERIDURAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRACAVITARY | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | MOUTHWASH / BUCCAL | 200 mg/1ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LOTION / TOPICAL | 0.85 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | FILM, EXTENDED RELEASE / TRANSDERMAL | 1.38 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / URETERAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SPRAY, METERED / NASAL | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / OPHTHALMIC | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / EPIDURAL | ADJ PH | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | OINTMENT / TOPICAL | 20 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRADERMAL | ADJ PH |
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 |
|---|---|---|---|---|---|---|
| 244b582b-350a-382e-e054-00144ff8d46c | 244b582b-3509-382e-e054-00144ff8d46c | 2015-11-11 | Warnings | 244b582b-350a-382e-e054-00144ff8d46c 244b582b-3509-382e-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.