FDA.reportPublic FDA data

Hello Kitty Fun Broad Spectrum SPF 40

Manufacturer
The Creme Shop Inc | Cosmax USA Corporation | Cosmax USA, Corporation
Effective date
2025-03-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:00:02

Label at a glance#

ProductHello Kitty Fun Broad Spectrum SPF 40
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

Directions Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating. Children under 6 months: Ask a doctor. 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 a Broad Spectrum SPF value of 15 or higher and other sun p...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Zinc Oxide 12.24%

OTC - PURPOSE SECTION

Purpose
Sunscreen

USES

INDICATIONS & USAGE SECTION

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 SECTION

Warnings
For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply generously and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months: Ask a doctor.
  • 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10am-2pm
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:
Water, Isoamyl Laurate, Glycerin,Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Polyglyceryl-10 Stearate, Poly C10-30 Alkyl Acrylate, Cetearyl Olivate, Polyhydroxystearic Acid, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Sorbitan Olivate, Hydroxyacetophenone, Phenoxyethanol, Polyglyceryl-10 Laurate, Microcrystalline Cellulose, Rubus Idaeus (Raspberry) Seed Oil, Xanthan Gum, Butylene Glycol, Cellulose Gum, Theobroma Cacao (Cocoa) Seed Extract.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other Information

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

QUESTIONS OR COMMENTS

OTHER SAFETY INFORMATION

Questions or Comments
Contact us at 1-866-993-4709 or lgbeauty.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TubeTube

CartonCarton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81123-331-01Hello Kitty Fun Broad Spectrum SPF 4050 mL in 1 TUBECREAM501
81123-331-01Hello Kitty Fun Broad Spectrum SPF 401 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81123-331HELLO KITTY FUN BROAD SPECTRUM SPF 40 (ZINC OXIDE) CREAM [THE CREME SHOP INC]1Current NDC, 2 package rows20250501_30d37581-122c-ec92-e063-6294a90ab425.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81123-33181123-331-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
POLYGLYCERYL-10 STEARATE90TF85HH91IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
BEHENYL ACRYLATE POLYMERD64PM5UT4UIACT
POLYGLYCERYL-10 LAURATEMPJ2Q8WI8GIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
RUBUS IDAEUS (RASPBERRY) SEED OIL9S8867952AIACT
WATER059QF0KO0RIACT
CELLULOSE GUMK679OBS311IACT
SORBITAN OLIVATEMDL271E3GRIACT
XANTHAN GUMTTV12P4NEEIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERINPDC6A3C0OXIACT
CETEARYL OLIVATE58B69Q84JOIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
COCOAD9108TZ9KGIACT
ZINC OXIDESOI2LOH54ZACTIB
ISOAMYL LAURATEM1SLX00M3MIACT

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
Hello Kitty Fun Broad Spectrum SPF 40ZINC OXIDEThe Creme Shop Inc30d37581-122c-ec92-e063-6294a90ab4252025-03-21WarningsExact identifier
ndc (package): 81123-331-01
ndc (product): 81123-331
ndc11 (package): 81123033101
spl id: 30d37581-122d-ec92-e063-6294a90ab425
spl set id: 30d37581-122c-ec92-e063-6294a90ab425

Reported adverse events (FAERS/openFDA)#

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