Label: 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
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Contains inactivated NDC Code(s)
NDC Code(s): 71797-222-02, 71797-223-02, 71797-224-02 - Packager: Beauty Sourcing, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated November 28, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- BB Cream with Spf 15 - Sunscreen. Drug Fact - Active Ingredient
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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.
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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 - Other informaton
- BB Cream with Spf 15 - Sunscreen. Drug Fact - Inactive ingredients
- BB Cream with Spf 15 - Sunscreen. Drug Fact - Questions Section
- BB Cream Light with Spf 15 - Sunscreen. Drug Fact section - Packaging (outer/inner) carton/container label
- BB Cream Medium with Spf 15 - Sunscreen. Drug Fact section - packagingouter2 label
- BB Cream Deep with Spf 15 - Sunscreen. Drug Fact section - packagingouter3 packagingInner3 label
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INGREDIENTS AND APPEARANCE
SIMPLY ME BEAUTY FOUNDATION CREAM LIGHT - SPF 15
octinoxate, titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71797-222 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.9 g in 59 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.9 g in 59 mL Inactive Ingredients Ingredient Name Strength 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 Shape RECTANGLE (box) Size 235620mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71797-222-02 59 mL in 1 TUBE; Type 0: Not a Combination Product 10/16/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/16/2017 SIMPLY ME BEAUTY FOUNDATION CREAM MEDIUM - SPF 15
octinoxate, titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71797-223 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.9 g in 59 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5.9 g in 59 mL Inactive Ingredients Ingredient Name Strength 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 Shape RECTANGLE (BOX) Size 235620mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71797-223-02 59 mL in 1 BOX; Type 0: Not a Combination Product 10/16/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/16/2017 SIMPLY ME BEAUTY FOUNDATION CREAM DEEP - SPF 15
octinoxate, titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71797-224 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.9 g in 59 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.9 g in 59 mL Inactive Ingredients Ingredient Name Strength 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 Shape RECTANGLE (BOX) Size 235620mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71797-224-02 59 mL in 1 BOX; Type 0: Not a Combination Product 10/16/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/16/2017 Labeler - Beauty Sourcing, LLC (080708275)
