Lucy Belle 011-01 2nd submittal

Manufacturer
LUCY BELLE BIOLOGICAL TECHNOLOGY CO., LTD.
Effective date
2021-06-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:43:53

Label at a glance#

ProductLAURA GELLER BETTER THAN BARE TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 50 Plus Sand 400
Active ingredientTITANIUM DIOXIDE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Label structure12 sections

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. Children under 6 years of age should be supervised when using. 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 value of 15 or higher, and other sun pr...

Storage and handling

Protect the product in this container from Excessive Sun and Heat.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10.0% ........... Sunscreen

Octisalate 5.0% .................. Sunscreen

Octocrylene 4.0% .............. Sunscreen

Titanium Dioxide 4.0% ....... Sunscreen

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

Helps prevent sunburn; if used as directed with other Sun Protection Measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

Do Not Use on damaged or broken skin.

OTC - WHEN USING SECTION

When Using This Product keep out of eyes, ears and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop Use and Ask a Doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep Out of Reach of Children. If swallowed, get medical help or contact the Poison Control Center Immediately.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

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.

Children under 6 years of age should be supervised when using.

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 value of 15 or higher, and other sun protection measures including: limiting time in the sun especially from 10 a.m. to 2 p.m.. Wear long sleeved shirts, pants, hats, and sunglasses.

children under 6 months: ask a doctor.

Other information

STORAGE AND HANDLING SECTION

Protect the product in this container from Excessive Sun and Heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Butylene Glycol, Polymethyl Methacrylate, Cyclopentasiloxane, Octyldodecanol, Octyldodecyl Xyloside, PEG-30 Dipolyhydroxystearate, Isononyl Isononanoate, Propanediol, Caprylic/Capric Triglyceride, Stearalkonium Hectorite, Propylene Carbonate, Cetyl PEG/PPG-10/1 Dimethicone, Lecithin, Polyhydroxystearic Acid, Ethylhexyl Palmitate, Isopropyl Myristate, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Dimethicone, Sodium Chloride, Triethoxycaprylylsilane, Styrene/butadiene copolymer, Phenoxyethanol, Caprylyl Glycol, Hydrogenated Coco-Glycerides, Alteromonas Ferment Extract, Helianthus Annuus (Sunflower) Seed Oil, Rosa Canina Fruit Oil, Tocopherol, Rosmarinus Officinalis (Rosemary) Extract, Vitis Vinifera (Grape) Seed Oil, Panthenol, Niacinamide, Cucumis Sativus (Cucumber) Fruit Extract. May Contain: Iron Oxides.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCartonTubeTube42 mL NDC: 81536-011-01

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81536-01181536-011-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

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
eeb805d0-256a-4784-e053-2a95a90ad2c7c3cf2fdb-44cc-d387-e053-2a95a90adcb32022-11-30WarningsExact identifier
spl set id: c3cf2fdb-44cc-d387-e053-2a95a90adcb3

Reported adverse events (FAERS/openFDA)#

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