FDA.reportPublic FDA data

BB Cream Broad Spectrum SPF 25 Light 01

Manufacturer
Allure Labs Inc
Effective date
2019-11-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:02:15

Label at a glance#

ProductBB Cream Broad Spectrum SPF 25 Light 01
Active ingredientZINC OXIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Zinc Oxide 21.0%

OTC - PURPOSE SECTION

Purpose: Sunscreen

INDICATIONS & USAGE SECTION

Uses:

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures, decreases the risk of skin cancer and  early skin aging  caused by the sun.

WARNINGS AND PRECAUTIONS SECTION

Warning: For external use only.

OTC - DO NOT USE SECTION

Do not use: on damaged or broken skin.

OTC - WHEN USING SECTION

When using this products:

  • 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.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Apply generously 15 minutes before sun exposer.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating. Immediatly after towel drying. at least every 2 hours.
  • Sun protection measures.Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a 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 sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months: ask a doctor.

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water (Aqua), Caprylyc/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Glyceryl Stearate, PEG-100 Stearate, Coco-Glucoside, Helianthus Annus, Caprylyl/Capryl Glucoside, Sclerotium Gum, Xanthan Gum, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Pyrus Malus (Apple) Fruit Extract, Cetearyl Glucoside, Tetrahexyldecyl Ascorbate, Butyrospermum Parkii (Shea) Butter, Coco-Caprylate/Caprate, Tocopherol, Sodium Hyaluronate, Phenoxyethanol, Ethylhexylglycerin, Polyacrylamide, C13-14 Isoparaffin, Laureth 7, Hydrolyzed Jojoba Esters, Citric Acid, Anthemis Nobilis Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis (Green Tea) Extract, Triethoxycaprylylsilane, Dimethicone, Fragrance, Limonene, Linalool, May contain +/-, Mica (Cl 77019), Titanium Dioxide (Cl 77891), Iron Oxides (Cl77491, Cl77492, Cl 77499).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FLOETIC BEAUTY LLC, DIST.

CLYDE HILL, WA 98004

MADE IN USA

WWW.FLOETICBEAUTY.COM

BB Cream BS SPF 25 Light 01BB Cream BS SPF 25 Light 01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62742-4178-22023-01-30C16284748780-1f386c649-bafb-0266-e053-dadaa90a7c1aDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62742-4178-1BB Cream Broad Spectrum SPF 25 Light 0120 mL in 1 BOTTLECREAM201
62742-4178-2BB Cream Broad Spectrum SPF 25 Light 011 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62742-4178BB CREAM BROAD SPECTRUM SPF 25 LIGHT 01 (ZINC OXIDE) CREAM [ALLURE LABS INC]1Legacy NDC, 2 package rows20191221_fa86fc6d-41ae-45a3-8d0d-bdafb2a0e5f2.zip

Products#

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

DailyMed product names page 1 of 2 · 47 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62742-417862742-4178-1, 62742-4178-2

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 46 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCONUT ALKANES1E5KJY107TIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
COCO GLUCOSIDEICS790225BIACT
SUNFLOWER OIL3W1JG795YIIACT
PHYTATE SODIUM88496G1ERLIACT
ALCOHOL3K9958V90MIACT
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0IACT
BETASIZOFIRAN2X51AD1X3TIACT
XANTHAN GUMTTV12P4NEEIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
ISOSTEARIC ACIDX33R8U0062IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
APPLEB423VGH5S9IACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
SHEA BUTTERK49155WL9YIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
TOCOPHEROLR0ZB2556P8IACT
HYALURONATE SODIUMYSE9PPT4THIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CHAMAEMELUM NOBILE FLOWERO2T154T6OGIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
DIMETHICONE92RU3N3Y1OIACT
LIMONENE, (+)-GFD7C86Q1WIACT

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
9b2d6c00-97a5-4c6a-91d0-0080c09f2a5cfa86fc6d-41ae-45a3-8d0d-bdafb2a0e5f22019-11-21WarningsExact identifier
spl id: 9b2d6c00-97a5-4c6a-91d0-0080c09f2a5c
spl set id: fa86fc6d-41ae-45a3-8d0d-bdafb2a0e5f2

Reported adverse events (FAERS/openFDA)#

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