Simply Me Beauty Foundation Cream Deep - SPF 15

Manufacturer
Beauty Sourcing, LLC
Effective date
2018-11-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:57:24

Label at a glance#

ProductSimply Me Beauty Foundation Cream Light - SPF 15
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure9 sections

Dosage and administration

Indications & Usage section is illustrated in the Directions section. • Apply generously 15 minutes before the sun exposure • Children under 6 months of age: ask a doctor. • Reapply at least every 2 hours.• Use a water-resistant sunscreen if swimming or seating. 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 sunscree...

Label contents#

Full prescribing information#

BB Cream with Spf 15 - Sunscreen. Drug Fact - Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsActive Ingredients

BB Cream with Spf 15 - Sunscreen. Drug Fact - Purpose and Use of Active Ingredients

OTC - PURPOSE SECTION

Purpose: Sunscreen

Use: Helps prevent sunburn.

BB Cream with Spf 15 - Sunscreen. Drug Fact - Warning Section

WARNINGS SECTION

For external use only

Skin Cancer / Skin Aging Alert

• Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

• Do not use on damaged or broken skin.

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• rash occurs.

Keep out of reach of children.

BB Cream with Spf 15 - Sunscreen. Drug Fact - Warning - Ask Doctor if

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

• rash occurs.

BB Cream with Spf 15 - Sunscreen. Drug Fact - Warning - DO Not Use

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.

BB Cream with Spf 15 - Sunscreen. Drug Fact - Warnings - Stop Use

OTC - STOP USE SECTION

Stop use and ask a doctor if • rash occurs.

BB Cream with Spf 15 - Sunscreen. Drug Fact - Warnings - Keep out Reach

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children is visible in the Warnings box of packaging.

Keep out of reach of children.

BB Cream with Spf 15 - Sunscreen. Drug Fact - Warnings - When Using

OTC - WHEN USING SECTION

When Using this product • Keep out of eyes. Rinse with water to remove.

BB Cream with Spf 15 - Sunscreen. Drug Fact - Directions

INDICATIONS & USAGE SECTION

Indications & Usage section is illustrated in the Directions section.

• Apply generously 15 minutes before the sun exposure • Children under 6 months of age: ask a doctor. • Reapply at least every 2 hours.• Use a water-resistant sunscreen if swimming or seating. 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 .

BB Cream with Spf 15 - Sunscreen. Drug Fact - Directions - Dosage and Admin

DOSAGE & ADMINISTRATION SECTION

BB cream Foundation with Sunscreen is a topical liquid. Apply generously 15 minutes before the sun exposure. May reapply at least every 2 hours.

BB Cream with Spf 15 - Sunscreen. Drug Fact - Other informaton

OTHER SAFETY INFORMATION

Other information. • Protect the product in this container from excessive heat and direct sunlight. • Store at room temperature: 15c - 30c (59f-86f).

BB Cream with Spf 15 - Sunscreen. Drug Fact - Inactive ingredients

INACTIVE INGREDIENT SECTION

BB cream with Spf 15 Inactive ingredients include:

Water(Aqua), Glycerin, Talc, Arlacel, Phenoxyethanol, Fragrance, May Contain: Red Iron Oxide (CI77491), Yellow Iron Oxides (CI77492)

BB Cream with Spf 15 - Sunscreen. Drug Fact - Questions Section

OTC - QUESTIONS SECTION

Question or Comments 1-800-255-0711

BB Cream Light with Spf 15 - Sunscreen. Drug Fact section - Packaging (outer/inner) carton/container label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package boxOuter Package box

Inner TubeInner Tube

BB Cream Medium with Spf 15 - Sunscreen. Drug Fact section - packagingouter2 label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagingouter2

packagingouter2packagingouter2

BB Cream Deep with Spf 15 - Sunscreen. Drug Fact section - packagingouter3 packagingInner3 label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagingouter3.jpg

packagingouter3packagingouter3

packagingInner3.jpg

packagingInner3packagingInner3

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71797-222-02Simply Me Beauty Foundation Cream Light - SPF 1559 mL in 1 TUBELIQUID592
71797-223-02Simply Me Beauty Foundation Cream Medium - SPF 1559 mL in 1 BOXLIQUID592
71797-224-02Simply Me Beauty Foundation Cream Deep - SPF 1559 mL in 1 BOXLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71797-222SIMPLY ME BEAUTY FOUNDATION CREAM LIGHT - SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID SIMPLY ME BEAUTY FOUNDATION CREAM MEDIUM - SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID SIMPLY ME BEAUTY FOUNDATION CREAM DEEP - SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [BEAUTY SOURCING, LLC]2Legacy NDC, 1 package rows20181129_62ea2933-4cfc-f7e1-e053-2a91aa0a0b15.zip
71797-223SIMPLY ME BEAUTY FOUNDATION CREAM LIGHT - SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID SIMPLY ME BEAUTY FOUNDATION CREAM MEDIUM - SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID SIMPLY ME BEAUTY FOUNDATION CREAM DEEP - SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [BEAUTY SOURCING, LLC]2Legacy NDC, 1 package rows20181129_62ea2933-4cfc-f7e1-e053-2a91aa0a0b15.zip
71797-224SIMPLY ME BEAUTY FOUNDATION CREAM LIGHT - SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID SIMPLY ME BEAUTY FOUNDATION CREAM MEDIUM - SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID SIMPLY ME BEAUTY FOUNDATION CREAM DEEP - SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [BEAUTY SOURCING, LLC]2Legacy NDC, 1 package rows20181129_62ea2933-4cfc-f7e1-e053-2a91aa0a0b15.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71797-22271797-222-02
71797-22371797-223-02
71797-22471797-224-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 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
7bc1d346-d6f2-75fc-e053-2a91aa0a520462ea2933-4cfc-f7e1-e053-2a91aa0a0b152018-11-28WarningsExact identifier
spl id: 7bc1d346-d6f2-75fc-e053-2a91aa0a5204
spl set id: 62ea2933-4cfc-f7e1-e053-2a91aa0a0b15

Reported adverse events (FAERS/openFDA)#

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