FDA.reportPublic FDA data

ETADERM Tattoo Sunscreen Broad Spectrum SPF-30

Manufacturer
NUEPHASE LLC
Effective date
2024-03-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:10:30

Label at a glance#

ProductETADERM Tattoo Sunscreen Broad Spectrum SPF-30
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

Helps prevent sun burn.  higher SPF gives more sun burn protection 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

Dosage and administration

Apply liberally15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. 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 broad spectrum SPF of 15 or higher and other sun protection ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • Helps prevent sun burn. 
  • higher SPF gives more sun burn protection
  • 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:

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding, 

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • 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 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.

Other Information:

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Ascorbic Acid (Vitamin E), Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calendula Officinalis Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Olivate, Cetyl Alcohol, Chamomilla Matricaria (Chamomile) Extract, Citric Acid, Cucumis Sativus (Cucumber) Extract, Daucus Carota Sativa (Carrot) Extract, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sun flower) Oil, Hydrolyzed Collagen, Polyhydroxy stearic Acid, Polysorbate 20, Rosa Canina (Rose) Hips Oil, Sorbitan Olivate, Theobroma Cacao (Cocoa)Butter, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84180-472-00ETADERM Tattoo Sunscreen Broad Spectrum SPF-30118 mL in 1 BOTTLECREAM1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84180-472ETADERM TATTOO SUNSCREEN BROAD SPECTRUM SPF-30 (ZINC OXIDE) CREAM [NUEPHASE LLC]1Current NDC, 1 package rows20240402_cc1e3485-57e6-4ac9-96b3-2d683beb5b53.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84180-47284180-472-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETEARYL OLIVATE58B69Q84JOIACT
CETYL ALCOHOL936JST6JCNIACT
CHAMOMILEFGL3685T2XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CUCUMBERYY7C30VXJTIACT
CARROTL56Z1JK48BIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL LAURATEY98611C087IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
POLYSORBATE 207T1F30V5YHIACT
SORBITAN OLIVATEMDL271E3GRIACT
COCOAD9108TZ9KGIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
XANTHAN GUMTTV12P4NEEIACT
CORN0N8672707OIACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ETADERM Tattoo Sunscreen Broad Spectrum SPF-30ZINC OXIDENUEPHASE LLCcc1e3485-57e6-4ac9-96b3-2d683beb5b532024-03-20WarningsExact identifier
ndc (package): 84180-472-00
ndc (product): 84180-472
ndc11 (package): 84180047200
spl id: 1414184a-a7b6-ff46-e063-6394a90a932b
spl set id: cc1e3485-57e6-4ac9-96b3-2d683beb5b53

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.