SIMPLY 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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BB Cream with SPF 15 - Sunscreen, Drug Fact

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

Active Ingredients

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

Purpose: Sunscreen

Use: Helps prevent sunburn.

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

Stop use and ask a doctor if

• rash occurs.

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

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

Stop use and ask a doctor if • rash occurs.

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

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

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 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

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 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

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

Question or Comments 1-800-255-0711

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

Outer Package box

Inner Tube

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

packagingouter2

packagingouter2

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

packagingouter3.jpg

packagingouter3

packagingInner3.jpg

packagingInner3

SIMPLY ME BEAUTY FOUNDATION CREAM LIGHT - SPF 15 
octinoxate, titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71797-222
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.9 g  in 59 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.9 g  in 59 mL
Inactive Ingredients
Ingredient NameStrength
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) 3.54 mL  in 59 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.295 mL  in 59 mL
ABRONIA FRAGRANS FLOWER (UNII: XAV1S68QBA) 0.118 mL  in 59 mL
GLYCERIN (UNII: PDC6A3C0OX) 7.08 mL  in 59 mL
TALC (UNII: 7SEV7J4R1U) 5.9 mL  in 59 mL
WATER (UNII: 059QF0KO0R) 30.27 mL  in 59 mL
Product Characteristics
Color    Score    
ShapeRECTANGLE (box) Size235620mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71797-222-0259 mL in 1 TUBE; Type 0: Not a Combination Product10/16/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/16/2017
SIMPLY ME BEAUTY FOUNDATION CREAM MEDIUM - SPF 15 
octinoxate, titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71797-223
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.9 g  in 59 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5.9 g  in 59 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 7.08 mL  in 59 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.295 mL  in 59 mL
WATER (UNII: 059QF0KO0R) 30.27 mL  in 59 mL
ABRONIA FRAGRANS FLOWER (UNII: XAV1S68QBA) 0.118 mL  in 59 mL
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) 3.54 mL  in 59 mL
TALC (UNII: 7SEV7J4R1U) 5.9 mL  in 59 mL
Product Characteristics
Color    Score    
ShapeRECTANGLE (BOX) Size235620mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71797-223-0259 mL in 1 BOX; Type 0: Not a Combination Product10/16/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/16/2017
SIMPLY ME BEAUTY FOUNDATION CREAM DEEP - SPF 15 
octinoxate, titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71797-224
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.9 g  in 59 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.9 g  in 59 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 7.08 mL  in 59 mL
TALC (UNII: 7SEV7J4R1U) 5.9 mL  in 59 mL
WATER (UNII: 059QF0KO0R) 30.27 mL  in 59 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.295 mL  in 59 mL
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) 3.54 mL  in 59 mL
ABRONIA FRAGRANS FLOWER (UNII: XAV1S68QBA) 0.118 mL  in 59 mL
Product Characteristics
Color    Score    
ShapeRECTANGLE (BOX) Size235620mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71797-224-0259 mL in 1 BOX; Type 0: Not a Combination Product10/16/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/16/2017
Labeler - Beauty Sourcing, LLC (080708275)

Revised: 11/2018
Document Id: 7bc1d346-d6f2-75fc-e053-2a91aa0a5204
Set id: 62ea2933-4cfc-f7e1-e053-2a91aa0a0b15
Version: 2
Effective Time: 20181128
 
Beauty Sourcing, LLC