FDA.reportPublic FDA data

Defend tattoo sunscreen SPF 30

Manufacturer
Rabbit Mad Tattoo LLC | Westwood Laboratories, LLC
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:44:56

Label at a glance#

ProductDefend tattoo sunscreen SPF 30
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

Helps prevebt sunburn.  Higher SPF gives more sunburn protection  If used as directed with other sun protection measures (see Diretions), decreases the risk of skin cancer and early skin aging caused by sun.

Dosage and administration

• Apply liberally 15 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 the risk, regularly use a    sunscreen with broad spectrum SPF of 15 or higher and other sun p...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 14.00 %

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • Helps prevebt sunburn. 
  • Higher SPF gives more sunburn protection 
  • If used as directed with other sun protection measures (see Diretions), decreases the risk of skin cancer and early skin aging caused by 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

OTC - STOP USE SECTION

if 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.

Directions:

DOSAGE & ADMINISTRATION SECTION

• Apply liberally 15 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 the 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.





Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Ascorbic Acid (Vitamin C), Benzyl Alcohol, Butyloctyl Salicylate, Calendula Officinalis Extract, Caprylic/Capric Triglyceride, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus(Cucumber) Extract, Daucus Carota Sativa (Carrot) Extract, Decyl Glucoside, Dehydroacetic Acid, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Hydroxyethylcellulose, Polyhydroxystearic Acid, Rosa Canina (Rose) Hips Oil, Stearic Acid, Theobroma Cacao (Cocoa) Butter, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.

Other Information:

SPL UNCLASSIFIED SECTION

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

Questions?

OTC - QUESTIONS SECTION

(323) 457 - 8763

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80396-079DEFEND TATTOO SUNSCREEN SPF 30 (ZINC OXIDE) CREAM [RABBIT MAD TATTOO LLC]4Legacy NDC20241222_aee2b32b-3b93-c49f-e053-2995a90a1f20.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
80396-07980396-079-00

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
ARGAN OIL4V59G5UW9XIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
BENZYL ALCOHOLLKG8494WBHIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CHAMOMILEFGL3685T2XIACT
CUCUMBERYY7C30VXJTIACT
CARROTL56Z1JK48BIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
DEHYDROACETIC ACID2KAG279R6RIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ROSE OILWUB68Y35M7IACT
STEARIC ACID4ELV7Z65APIACT
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
5073ca83-27ed-97f0-e063-6294a90a65c8aee2b32b-3b93-c49f-e053-2995a90a1f202026-04-27WarningsExact identifier
spl set id: aee2b32b-3b93-c49f-e053-2995a90a1f20

Reported adverse events (FAERS/openFDA)#

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