FDA.reportPublic FDA data

SENSITIVE MINERAL FACE ZINC OXIDE PROTECTION 35

Manufacturer
Shenzhen XiaoMai Manufacturing Co., Ltd.
Effective date
2024-04-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:06:02

Label at a glance#

ProductBBULUBIU SENSITIVE MINERAL FACE ZINC OXIDE PROTECTION 35ULUBIU SENSITIVE MINERAL FACE ZINC OXIDE PROTECTION 35
Active ingredientOCTOCRYLENE, TITANIUM DIOXIDE, NIACINAMIDE, CERAMIDE 1, CERAMIDE 3, HOMOSALATE, ZINC OXIDE, CERAMIDE 6 II
Label structure12 sections

Indications and uses

decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating.

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Homosalate: 10%
Titanium Dioxide: 5%
Octocrylene: 2%
Zinc Oxide: 9%
Niacinamide: 4%
Ceramide 3: 0.5%
Ceramide 6 II: 0.5%
Ceramide 1: 0.5%
Sodium Hyaluronate: 1.5%
Collagen: 1.5%
Centella Asiatica Extract: 2.5%

PURPOSE

OTC - PURPOSE SECTION

helps prevent sunburn.

Uses

INDICATIONS & USAGE SECTION

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 - STOP 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 occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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

Directions for use

DOSAGE & ADMINISTRATION SECTION

apply liberally 15 minutes before sun exposure.
reapply at least every 2 hours.
use a water resistant sunscreen if swimming or sweating.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Cetearyl Alcohol: 4.5%
Ethylcellulose: 1%
Carbomer: 0.2%
Disodium EDTA: 0.6%
Glycerin: 5.5%
Dimethicone: 3.5%
Behentrimonium Methosulfate: 1.5%
Aluminum Starch Octenylsuccinate: 2%
Propylparaben: 0.6%
Sodium Lauroyl Aspartate: 0.3%
Phytosphingosine: 0.2%
Lactic Acid: 0.2%
Xanthan Gum: 0.2%
Aqua: 42.7%

Other Information

STORAGE AND HANDLING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83872-101BBULUBIU SENSITIVE MINERAL FACE ZINC OXIDE PROTECTION 35ULUBIU SENSITIVE MINERAL FACE ZINC OXIDE PROTECTION 35 (SENSITIVE MINERAL FACE ZINC OXIDE PROTECTION 35) CREAM [SHENZHEN XIAOMAI MANUFACTURING CO., LTD.]1Unmatched20240412_15bbb407-e347-835b-e063-6394a90a9b97.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83872-10183872-101-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
BEHENTRIMONIUM METHOSULFATE5SHP745C61IACT
OCTOCRYLENE5A68WGF6WMACTIB
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT
DIMETHICONE92RU3N3Y1OIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
NIACINAMIDE25X51I8RD4ACTIB
CERAMIDE 15THT33P7X7ACTIB
CERAMIDE 34370DF050BACTIB
HOMOSALATEV06SV4M95SACTIB
SODIUM LAUROYL ASPARTATE328G13N8ZRIACT
LACTIC ACID33X04XA5ATIACT
ZINC OXIDESOI2LOH54ZACTIB
CERAMIDE 6 IIF1X8L2B00JACTIB
PHYTOSPHINGOSINEGIN46U9Q2QIACT

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
36583a71-eac5-5ac6-e063-6294a90aaf1315bbb407-e347-835b-e063-6394a90a9b972025-05-30WarningsExact identifier
spl set id: 15bbb407-e347-835b-e063-6394a90a9b97

Reported adverse events (FAERS/openFDA)#

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