Indications and uses
HELPS PREVENT SUBBURN 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.
DRUNK ELEPHANT UMBRA SHEER DEFENSE
- Manufacturer
- Drunk Elephant Distributors, LLC
- Effective date
- 2020-01-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:42:03
Label at a glance#
ProductDRUNK ELEPHANT UMBRA SHEER DEFENSE SPF-30
Active ingredientZINC OXIDE
Label structure13 sections
Dosage and administration
APPLY LIBERALLY 20 MINUTES PRIOR TO SUN EXPOSURE AS NEEDED. REAPPLY: AFTER SWIMMING OR SWEATING, IMMEDIATELY AFTER TOWEL DRYING, AT LEAST EVERY TWO HOURS. DO NOT USE ON INFANTS UNDER 6 MONTHS OF AGE. SUN PROTECTION MEASURES. SPENDING TIME IN THE SUN INCREEASES 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 PROT...
Label contents#
Full prescribing information#
ACTIVE INGREDIENT
ZINC OXIDE 20%
PURPOSE
SUNSCREEN
USES
- HELPS PREVENT SUBBURN
- 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 - 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 POSON CONTROL CENTER RIGHT AWAY.
DIRECTIONS
- APPLY LIBERALLY 20 MINUTES PRIOR TO SUN EXPOSURE AS NEEDED.
- REAPPLY:
- AFTER SWIMMING OR SWEATING,
- IMMEDIATELY AFTER TOWEL DRYING,
- AT LEAST EVERY TWO HOURS.
- DO NOT USE ON INFANTS UNDER 6 MONTHS OF AGE.
- SUN PROTECTION MEASURES. SPENDING TIME IN THE SUN INCREEASES 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-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
INACTIVE INGREDIENTS
ACETYL GLUCOSAMINE, ALGAE EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCOL, CETEARYL ALCOHOL, COCOS NUCIFERA (COCONUT) OIL, DICAPRYLYL CARBONATE, DISODIUM EDTA, GLYCERIN, HAEMALECOCCUS PINNALIS EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HELIANTHUS ANNUUS (SUNFLOWER) SPROUT EXTRACT, HYDROLYZED WHEAT PROTEIN, LECITHIN, MICA, CARMINE (CI 75470), PENTYLENE GLYCOL, PHENOXYETHANOL, POLYHYDROXYSTEARIC ACID, POTASSIUM SORBATE, PROPANEDIOL, RASPBERRY SEED OIL, TOCOPHERYL SUCCINATE AMINOPROPANEDIOL ESTERS, SCLEROCARYA BIRREA (MARULA) SEED OIL, SEA WATER, SILICA, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, STEARETH-2, STEARETH-21, SUCROSE, TETRAHEXYLDECYL ASCORBATE, TOCOPHEROL, TRIETHOXYCAPRYLYLSILANE, VITIS VINIFERA (GRAPE) JUICE EXTRACT, WATER (AQUA), XANTHAN GUM
OTHER INFORMATION
- PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.
QUESTIONS OR COMMENTS
- INFO@DRUNKELEPHANT.COM
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69455-101-14 | 2020-02-03 | C162847 | 48780-1 | 9d75b9d0-f5fe-f424-e053-dadaa90a57ce | a4bc7f2c-5a56-46a3-ac1c-6aafa0b523c3 |
| 69455-101-14 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f5fe-f424-e053-dadaa90a57ce | a4bc7f2c-5a56-46a3-ac1c-6aafa0b523c3 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 3 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 3 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 3 | |
| .ALPHA.-TOCOPHEROL SUCCINATE, D- | INACTIVE INGREDIENT | LU4B53JYVE | 3 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 3 | |
| ASTAXANTHIN | INACTIVE INGREDIENT | 8XPW32PR7I | 3 | |
| CAPRYLHYDROXAMIC ACID | INACTIVE INGREDIENT | UPY805K99W | 3 | |
| CAPRYLYL GLYCOL | INACTIVE INGREDIENT | 00YIU5438U | 3 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 3 | |
| CHONDRUS CRISPUS | INACTIVE INGREDIENT | OQS23HUA1X | 3 | |
| COCONUT OIL | INACTIVE INGREDIENT | Q9L0O73W7L | 3 | |
| DICAPRYLYL CARBONATE | INACTIVE INGREDIENT | 609A3V1SUA | 3 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 3 | |
| EGG PHOSPHOLIPIDS | INACTIVE INGREDIENT | 1Z74184RGV | 3 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 3 | |
| GLYCINE | INACTIVE INGREDIENT | TE7660XO1C | 3 | |
| HELIANTHUS ANNUUS SPROUT | INACTIVE INGREDIENT | 4P26HG1S5W | 3 | |
| JOJOBA OIL | INACTIVE INGREDIENT | 724GKU717M | 3 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 3 | |
| N-ACETYLGLUCOSAMINE | INACTIVE INGREDIENT | V956696549 | 3 | |
| PENTYLENE GLYCOL | INACTIVE INGREDIENT | 50C1307PZG | 3 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 3 | |
| POLYHYDROXYSTEARIC ACID (2300 MW) | INACTIVE INGREDIENT | YXH47AOU0F | 3 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | 3 | |
| PROPANEDIOL | INACTIVE INGREDIENT | 5965N8W85T | 3 | |
| RASPBERRY SEED OIL | INACTIVE INGREDIENT | 9S8867952A | 3 | |
| SCLEROCARYA BIRREA SEED OIL | INACTIVE INGREDIENT | WDO4TLS35F | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 3 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 3 | |
| STEARETH-2 | INACTIVE INGREDIENT | V56DFE46J5 | 3 | |
| STEARETH-21 | INACTIVE INGREDIENT | 53J3F32P58 | 3 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 3 | |
| SUNFLOWER OIL | INACTIVE INGREDIENT | 3W1JG795YI | 3 | |
| TETRAHEXYLDECYL ASCORBATE | INACTIVE INGREDIENT | 9LBV3F07AZ | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 3 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | 3 | |
| TRIETHOXYCAPRYLYLSILANE | INACTIVE INGREDIENT | LDC331P08E | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 3 | |
| WHEAT | INACTIVE INGREDIENT | 4J2I0SN84Y | 3 | |
| WINE GRAPE JUICE | INACTIVE INGREDIENT | JHQ6158A7R | 3 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 3 |
Products#
Every source-derived product name is available through these pages.
- DRUNK ELEPHANT UMBRA SHEER DEFENSE SPF-30
- ZINC OXIDE
- DICAPRYLYL CARBONATE
- GLYCERIN
- PENTYLENE GLYCOL
- STEARETH-2
- CETOSTEARYL ALCOHOL
- STEARETH-21
- SODIUM CHLORIDE
- CHONDRUS CRISPUS
- ALOE VERA LEAF
- ASTAXANTHIN
- HELIANTHUS ANNUUS SPROUT
- WINE GRAPE JUICE
- WHEAT
- COCONUT OIL
- SUNFLOWER OIL
- JOJOBA OIL
- SCLEROCARYA BIRREA SEED OIL
- N-ACETYLGLUCOSAMINE
- TETRAHEXYLDECYL ASCORBATE
- RASPBERRY SEED OIL
- .ALPHA.-TOCOPHEROL ACETATE
- TOCOPHEROL
- GLYCINE
- SUCROSE
- EGG PHOSPHOLIPIDS
- SILICON DIOXIDE
- POLYHYDROXYSTEARIC ACID (2300 MW)
- CAPRYLHYDROXAMIC ACID
- EDETATE DISODIUM
- TRIETHOXYCAPRYLYLSILANE
- XANTHAN GUM
- PROPANEDIOL
- CAPRYLYL GLYCOL
- POTASSIUM SORBATE
- PHENOXYETHANOL
- MICA
- TITANIUM DIOXIDE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69455-101 | 69455-101-14 |
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 |
|---|---|---|---|---|---|---|
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, EMULSION / INTRAVENOUS | 0.62 %w/v | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 1 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | INJECTION, EMULSION / INTRAVENOUS | 0.02 %w/v | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / RECTAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | JELLY / NASAL | NA | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER / ORAL | 275 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | AEROSOL, FOAM / TOPICAL | 8 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRATHECAL | 131 mg | ||
| GLYCINE | GLYCINE | TE7660XO1C | POWDER / RESPIRATORY (INHALATION) | 2 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | ELIXIR / ORAL | 1.3 mg/5ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION/ DROPS / AURICULAR (OTIC) | 3 mg | ||
| GLYCINE | GLYCINE | TE7660XO1C | INJECTION, SOLUTION / INTRAVENOUS | 0.42 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / SUBLINGUAL | 10 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | CAPSULE, LIQUID FILLED / ORAL | NA | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | TABLET / ORAL | 0.08 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 9.4 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / NASAL | 0.1 mg/1ml | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LIQUID / ORAL | 0.5 mg/1ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRACARDIAC | 70 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SPRAY / NASAL | 30 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CAPSULE / ORAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CONCENTRATE / ORAL | 20 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / AURICULAR (OTIC) | 0.1 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY, METERED / NASAL | 4 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER, DENTIFRICE / DENTAL | 0.03 mg/mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL | 1.35 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, COATED / ORAL | 0.21 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING / ORAL | 0.15 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | PASTILLE / ORAL | 426 mg | ||
| GLYCINE | GLYCINE | TE7660XO1C | CAPSULE / ORAL | 62 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, FILM COATED / ORAL | 4 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAVASCULAR | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / RESPIRATORY (INHALATION) | 0.01 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 360 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / INTRAVENOUS | 7 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 2000 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1800 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRACARDIAC | 2 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 |
|---|---|---|---|---|---|---|
| 857d004e-2b8c-44f3-80d6-f899910c45c7 | a4bc7f2c-5a56-46a3-ac1c-6aafa0b523c3 | 2020-01-22 | Warnings | 857d004e-2b8c-44f3-80d6-f899910c45c7 a4bc7f2c-5a56-46a3-ac1c-6aafa0b523c3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.