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NDC 69455-0463-11 Drunk Elephant 20 mg/100mL Details
Drunk Elephant 20 mg/100mL
Drunk Elephant is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Drunk Elephant, LLC. The primary component is ZINC OXIDE.
Product Information
| NDC | 69455-0463 |
|---|---|
| Product ID | 69455-463_8e80f47b-c919-43cf-83e3-c228f76b524d |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Drunk Elephant |
| Proprietary Name Suffix | Umbre Tinte Physical Daily Defense Protection SPF-30 |
| Non-Proprietary Name | Zinc Oxide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/100mL |
| Substance Name | ZINC OXIDE |
| Labeler Name | Drunk Elephant, LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part352 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 69455-0463-11 (69455046311)
| NDC Package Code | 69455-463-11 |
|---|---|
| Billing NDC | 69455046311 |
| Package | 1 TUBE in 1 BOX (69455-463-11) / 60 mL in 1 TUBE |
| Marketing Start Date | 2019-01-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 272689a1-476c-426b-9c3e-c9fde4e1bf06 Details
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
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
-
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
Inactive ingredients
water, caprylic/capric triglyceride, dicaprylyl carbonate, glycerin, pentylene glycol, 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, sodium C14-16 olefin sulfonate, phenoxyethanol, chlorphenesin, sodium dehydroacetate, iron oxides (CI 77491, CI 77492, CI 77499)
PRINCIPAL DISPLAY PANEL - 60 ml Tube Box
INGREDIENTS AND APPEARANCE
| DRUNK ELEPHANT
UMBRE TINTE PHYSICAL DAILY DEFENSE PROTECTION SPF-30
zinc oxide lotion |
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| Labeler - Drunk Elephant, LLC (057204632) |
Revised: 8/2022
Document Id: 8e80f47b-c919-43cf-83e3-c228f76b524d
Set id: 272689a1-476c-426b-9c3e-c9fde4e1bf06
Version: 3
Effective Time: 20220808