Label: DRUNK ELEPHANT UMBRE SHEER DEFENSE SPF-30- zinc oxide lotion
- NDC Code(s): 69455-964-15
- Packager: Drunk Elephant, LLC
- 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 August 8, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
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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
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Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
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Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging.
To decrease the 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-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
- Other information
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Inactive ingredients
water, caprylic/capric triglyceride, dicaprylyl carbonate, pentylene glycol, glycerin, steareth-2, propanediol, steareth-21, polyhydroxystearic acid, cetearyl alcohol, silica, sclerocarya birrea seed oil, aloe barbadensis leaf extract, chondrus crispus extract, haematococcus pluvialis extract, helianthus annuus (sunflower) sprout extract, vitis vinifera (grape) juice extract, helianthus annuus (sunflower) seed oil, simmondsia chinensis (jojoba) seed oil, raspberry seed oil/tocopheryl succinate aminopropanediol esters, hydrolyzed wheat protein, tocopheryl acetate, tocopherol, sea water, acetyl glucosamine, cetearyl glucoside, sodium stearoyl glutamate, tetrahexyldecyl ascorbate, glycine, sucrose, lecithin, triethoxycaprylylsilane, xanthan gum, trisodium ethylenediamine disuccinate, caprylhydroxamic acid, caprylyl glycol, phenoxyethanol, chlorphenesin, sodium dehydroacetate, iron oxides (CI 77491)
- Questions or comments
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 90 ml Tube Box
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INGREDIENTS AND APPEARANCE
DRUNK ELEPHANT UMBRE SHEER DEFENSE SPF-30
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69455-964 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 mg in 100 mL Inactive Ingredients Ingredient Name Strength DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) GLYCERIN (UNII: PDC6A3C0OX) PENTYLENE GLYCOL (UNII: 50C1307PZG) STEARETH-2 (UNII: V56DFE46J5) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) STEARETH-21 (UNII: 53J3F32P58) SODIUM CHLORIDE (UNII: 451W47IQ8X) CHONDRUS CRISPUS (UNII: OQS23HUA1X) ALOE VERA LEAF (UNII: ZY81Z83H0X) HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W) WINE GRAPE JUICE (UNII: JHQ6158A7R) WHEAT (UNII: 4J2I0SN84Y) SUNFLOWER OIL (UNII: 3W1JG795YI) JOJOBA OIL (UNII: 724GKU717M) SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F) N-ACETYLGLUCOSAMINE (UNII: V956696549) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) RASPBERRY SEED OIL (UNII: 9S8867952A) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TOCOPHEROL (UNII: R0ZB2556P8) GLYCINE (UNII: TE7660XO1C) SUCROSE (UNII: C151H8M554) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) EDETATE DISODIUM (UNII: 7FLD91C86K) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) XANTHAN GUM (UNII: TTV12P4NEE) PROPANEDIOL (UNII: 5965N8W85T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) CHLORPHENESIN (UNII: I670DAL4SZ) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69455-964-15 1 in 1 BOX 12/13/2018 1 90 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/13/2018 Labeler - Drunk Elephant, LLC (057204632)
