FDA.reportPublic FDA data

LUCKY 13s ALL NATURAL TATTOO SUNSCREEN SPF-30

Manufacturer
SALES BRAIN HOLDINGS LLC
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:00:15

Label at a glance#

ProductLUCKY 13s ALL NATURAL TATTOO SUNSCREEN SPF-30
Active ingredientZINC OXIDE
Label structure7 sections

Indications and uses

• Helps prevent sunburn. • Higher SPF gives more sunburn 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 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. • 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 includ...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 14.00%

PURPOSE:

OTC - PURPOSE SECTION

Sunscreen

USES:

INDICATIONS & USAGE SECTION

• Helps prevent sunburn. • Higher SPF gives more sunburn 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

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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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. • 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.





Sun Protection Measures.

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), Benzyl Alcohol, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Cannabis Sativus (Hemp) Seed Oil, Caprylic/Capric Triglyceride, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Dodecane, Dehydroacetic Acid, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Extract, Stearic Acid, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Xanthan Gum, Zemea (Corn) Propanediol.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82459-249-00LUCKY 13s ALL NATURAL TATTOO SUNSCREEN SPF-30120 mL in 1 BOTTLECREAM1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82459-249LUCKY 13S ALL NATURAL TATTOO SUNSCREEN SPF-30 (ZINC OXIDE) CREAM [SALES BRAIN HOLDINGS LLC]2Current NDC, Legacy NDC, 1 package rows20231112_ec06bc4b-90d6-4b41-9086-f57737a34d91.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82459-24982459-249-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
BENZYL ALCOHOLLKG8494WBHIACT
SHEA BUTTERK49155WL9YIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
HEMPTD1MUT01Q7IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATERMELON231473QB6RIACT
COCONUT OILQ9L0O73W7LIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
DODECANE11A386X1QHIACT
DEHYDROACETIC ACID2KAG279R6RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
PUNICA GRANATUM ROOT BARKCLV24I3T1DIACT
STEARIC ACID4ELV7Z65APIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
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
LUCKY 13s ALL NATURAL TATTOO SUNSCREEN SPF-30ZINC OXIDESALES BRAIN HOLDINGS LLCec06bc4b-90d6-4b41-9086-f57737a34d912023-11-11WarningsExact identifier
ndc (package): 82459-249-00
ndc (product): 82459-249
ndc11 (package): 82459024900
spl id: 09e3156c-9361-43f6-e063-6394a90ad71e
spl set id: ec06bc4b-90d6-4b41-9086-f57737a34d91

Reported adverse events (FAERS/openFDA)#

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