Drug Facts

Manufacturer
IT COSMETICS, LLC | Beauty Manufacturing Solutions Corp.
Effective date
2023-12-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:06:06

Label at a glance#

Productit cosmetics Bye Bye Foundation Full Coverage Moisturizer Broad Spectrum 50 Plus Sunscreen All Shades
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure13 sections

Indications and 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

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

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 8.9%

Zinc oxide  6.3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

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 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 if

OTC - STOP USE SECTION

rash occurs

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.

Directions

DOSAGE & ADMINISTRATION SECTION

● shake well before use

● apply liberally 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● 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 10 a.m. – 2 p.m.

   ● wear long-sleeved shirts, pants, hats, and sunglasses

● children under 6 months of age: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, phenyl trimethicone, dimethicone, butylene glycol, butylene glycol dicaprylate/dicaprate, orbignya oleifera seed oil, butyloctyl salicylate, cetyl PEG/PPG-10/1 dimethicone, cyclopentasiloxane, snail secretion filtrate, aluminum hydroxide, magnesium sulfate, polyglyceryl-4 isostearate,, stearic acid,, cyclohexasiloxane, dimethicone/vinyl dimethicone crosspolymer, hexyl laurate, calcium stearate, caprylyl glycol, triethoxycaprylylsilane, ethyl hexanediol, ethylhexylglycerin, limonene, phenoxyethanol, citrus limon (lemon) peel oil, sorbitan isostearate, tocopheryl acetate, 1,2-hexanediol, citrus aurantium bergamia (bergamot) fruit oil, disodium EDTA, citrus aurantium dulcis (orange) peel oil, citrus aurantifolia (lime) oil, pinus sylvestris leaf oil, niacinamide, punica granatum seed oil, vitis vinifera (grape) seed oil, cholesterol, cholesteryl oleyl carbonate, persea gratissima (avocado) oil, polymethylsilsesquioxane, anthemis nobilis flower water, lactobacillus/dipteryx odorata seed ferment filtrate, lactobacillus/pumpkin ferment extract, linalool, panax ginseng root extract, avena sativa (oat) kernel extract, eucalyptus globulus leaf oil, saccharomyces/rice ferment filtrate, lactobacillus/kelp ferment filtrate, cholesteryl isostearate, citral, cholesteryl chloride, cholesteryl nonanoate, curcuma longa (turmeric) root extract, perfluorohexane, glycerin, leuconostoc/radish root ferment filtrate, magnolia kobus bark extract, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, camellia sinensis leaf extract, glycine soja (soybean) sprout extract, perfluorodecalin, silk extract, hydrolyzed silk, perfluoromethylcyclopentane, silica, steareth-20, citric acid, saccharum officinarum (sugarcane) extract, cocos nucifera (coconut) fruit extract, hydrolyzed collagen, saccharomyces/camellia sinensis extract ferment filtrate, bacillus/cordyceps sinensis/ganoderma lucidum/inonotus obliquus/lentinus edodes/phellinus linteus/schizophyllum commune/tricholoma matsutake extract ferment filtrate, phaseolus angularis seed extract, lactobacillus ferment, lactobacillus/centella asiatica/gleditsia sinensis thorn/houttuynia cordata extract/phellodendron amurense bark/polygonum cuspidatum root/prunella vulgaris/torilis japonica extract ferment filtrate, lactobacillus/rice ferment filtrate, sodium benzoate, chrysanthemum indicum flower extract, potassium sorbate, BHT, diamond powder, lactobacillus/honeysuckle flower/licorice root/morus alba root/pueraria lobata root/schisandra chinensis fruit/scutellaria baicalensis root/sophora japonica flower extract ferment filtrate, aloe barbadensis leaf extract, caprylhydroxamic acid, olea europaea (olive) leaf extract, artemisia princeps leaf extract, cinnamomum cassia bark extract, pueraria lobata root extract, diospyros kaki leaf extract, morus alba fruit extract, chlorhexidine digluconate, n-hydroxysuccinimide, biotin, thiamine HCL, niacin, folic acid, retinyl palmitate, carnitine HCL, riboflavin, tocopherol, ascorbic acid, pantothenic acid, sodium citrate, palmitoyl tripeptide-1, hydrolyzed hyaluronic acid, chrysin, palmitoyl tetrapeptide-7; may contain: titanium dioxide, iron oxides

Questions or comments?

OTC - QUESTIONS SECTION

Call 800-620-3956

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a labelimage of a label

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DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69259-2888-1it cosmetics Bye Bye Foundation Full Coverage Moisturizer Broad Spectrum 50 Plus Sunscreen All Shades75 mL in 1 TUBELOTION754
69259-2888-1it cosmetics Bye Bye Foundation Full Coverage Moisturizer Broad Spectrum 50 Plus Sunscreen All Shades1 in 1 CARTONLOTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69259-2888IT COSMETICS BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER BROAD SPECTRUM 50 PLUS SUNSCREEN ALL SHADES (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [IT COSMETICS, LLC]4Current NDC, Legacy NDC, 2 package rows20231231_34f0c2c9-a5bc-4b25-bfc1-336dcbb353e4.zip

Products#

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

DailyMed product names page 1 of 3 · 99 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69259-288869259-2888-1

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 97 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
it cosmetics Bye Bye Foundation Full Coverage Moisturizer Broad Spectrum 50 Plus Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC34f0c2c9-a5bc-4b25-bfc1-336dcbb353e42023-12-30WarningsExact identifier
ndc (package): 69259-2888-1
ndc (product): 69259-2888
ndc11 (package): 69259288801
spl id: a3ca8ffa-5eb1-488a-b77e-5cef704ccc9d
spl set id: 34f0c2c9-a5bc-4b25-bfc1-336dcbb353e4

Reported adverse events (FAERS/openFDA)#

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