Label: INDUSTRIAL LIP BALM SPF 15- octinoxate and oxybenzone lipstick
CLEANROOM LIP BALM SPF 15- octinoxate and oxybenzone lipstick
DESERT SPIRIT LIP BALM SPF 15- octinoxate and oxybenzone lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 59555-111-20, 59555-112-20, 59555-113-20 - Packager: R & R Lotion, Inc
- 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 October 20, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
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Inactive Ingredients
Aloe Barbadensis (Aloe Vera) Leaf Extract, Copernicia Cerifera (Carnauba) Wax, Flavor, Mineral Oil, Paraffin, Petrolatum, Retinyl Palmitate, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol (Vitamin E), Zea Mays (Corn) Oil (and) BHA (and) Propyl Gallate (and) Citric Acid.
- Other Information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Industrial
- PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Clean Balm
- PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Desert Spirit
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INGREDIENTS AND APPEARANCE
INDUSTRIAL LIP BALM SPF 15
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59555-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 30 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Carnauba Wax (UNII: R12CBM0EIZ) Mineral Oil (UNII: T5L8T28FGP) Paraffin (UNII: I9O0E3H2ZE) Petrolatum (UNII: 4T6H12BN9U) Vitamin A Palmitate (UNII: 1D1K0N0VVC) Jojoba Oil (UNII: 724GKU717M) Cocoa Butter (UNII: 512OYT1CRR) Corn Oil (UNII: 8470G57WFM) Propyl Gallate (UNII: 8D4SNN7V92) Citric Acid Monohydrate (UNII: 2968PHW8QP) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) Product Characteristics Color YELLOW Score Shape Size Flavor LIME (Lime Burst) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59555-111-20 4.2 g in 1 APPLICATOR; Type 0: Not a Combination Product 01/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2020 CLEANROOM LIP BALM SPF 15
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59555-112 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 30 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Carnauba Wax (UNII: R12CBM0EIZ) Mineral Oil (UNII: T5L8T28FGP) Paraffin (UNII: I9O0E3H2ZE) Petrolatum (UNII: 4T6H12BN9U) Vitamin A Palmitate (UNII: 1D1K0N0VVC) Jojoba Oil (UNII: 724GKU717M) Cocoa Butter (UNII: 512OYT1CRR) Corn Oil (UNII: 8470G57WFM) Propyl Gallate (UNII: 8D4SNN7V92) Citric Acid Monohydrate (UNII: 2968PHW8QP) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) Product Characteristics Color YELLOW Score Shape Size Flavor LIME (Lime Burst) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59555-112-20 4.2 g in 1 APPLICATOR; Type 0: Not a Combination Product 01/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2020 DESERT SPIRIT LIP BALM SPF 15
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59555-113 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 30 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Carnauba Wax (UNII: R12CBM0EIZ) Mineral Oil (UNII: T5L8T28FGP) Paraffin (UNII: I9O0E3H2ZE) Petrolatum (UNII: 4T6H12BN9U) Vitamin A Palmitate (UNII: 1D1K0N0VVC) Jojoba Oil (UNII: 724GKU717M) Cocoa Butter (UNII: 512OYT1CRR) Corn Oil (UNII: 8470G57WFM) Propyl Gallate (UNII: 8D4SNN7V92) Citric Acid Monohydrate (UNII: 2968PHW8QP) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) Product Characteristics Color YELLOW Score Shape Size Flavor LIME (Lime Burst) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59555-113-20 4.2 g in 1 APPLICATOR; Type 0: Not a Combination Product 01/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2020 Labeler - R & R Lotion, Inc (062979000)