Label: HYDRATING SHEER LIP BALM SPF 30 - TRIO- avobenzone, octisalate, and homosalate kit
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Contains inactivated NDC Code(s)
NDC Code(s): 49358-564-01, 49358-565-01, 49358-566-01, 49358-567-01 - Packager: MDSolarSciences
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 August 6, 2019
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 INGREDIENT
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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.
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure & again after swimming or sweating.
- Reapply at least every 2 hours.
- Children under 6 months: Ask a doctor
- Sun Protection Measures: To decrease your risk of skin cancer and early skin aging, regularly use a sunscreen of SPF15 or higher and other sun protective measures including:
- Limit time in the sun, especially from 10a.m.-2p.m.
- Wear long-sleeved shirts, pants, hats and sunglasses
- Other Information
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Inactive Ingredients
Persea Gratissima (Avocado) Oil, Butyrospermum Parkii (Shea) Butter, Paraffin Wax, Hydrogenated Soybean Oil, Ricinus Communis (Castor) Seed Oil, Octyldodecanol, Olea Europaea (Olive) Fruit Oil, Jojoba Esters, Hydrogenated Vegetable Oil, Microcrystalline Wax, Stearic Acid, Helianthus Annuus (Sunflower) Seed Oil, Squalane, Acacia Decurrens Flower Wax, Polyglycerin-3, Rhus Verniciflua Peel Wax, Sorbitan Oleate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Ascorbyl Palmitate, Tocopherol. May contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491- Red), Iron Oxides (CI 77492 - Yellow), Iron Oxides (CI 77499 - Black) CI 19140 - Yellow 5, Red 28 Lake (CI 45410)
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
HYDRATING SHEER LIP BALM SPF 30 - TRIO
avobenzone, octisalate, and homosalate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49358-567 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49358-567-01 1 in 1 CARTON 10/01/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 APPLICATOR 4.2 g Part 2 1 APPLICATOR 4.2 g Part 3 1 APPLICATOR 4.2 g Part 1 of 3 HYDRATING SHEER LIP BALM SPF 30 - RED BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN
avobenzone, octisalate, and homosalate lipstickProduct Information Item Code (Source) NDC:49358-564 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 30 mg in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50 mg in 1 g Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 100 mg in 1 g Inactive Ingredients Ingredient Name Strength Avocado Oil (UNII: 6VNO72PFC1) Shea Butter (UNII: K49155WL9Y) PARAFFIN (UNII: I9O0E3H2ZE) HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C) Castor Oil (UNII: D5340Y2I9G) OCTYLDODECANOL (UNII: 461N1O614Y) OLIVE OIL (UNII: 6UYK2W1W1E) HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) CORN OIL (UNII: 8470G57WFM) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) STEARIC ACID (UNII: 4ELV7Z65AP) SUNFLOWER OIL (UNII: 3W1JG795YI) SQUALANE (UNII: GW89575KF9) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBYL PALMITATE (UNII: QN83US2B0N) TOCOPHEROL (UNII: R0ZB2556P8) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 28 (UNII: 767IP0Y5NH) Product Characteristics Color RED Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49358-564-01 4.2 g in 1 APPLICATOR; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 10/01/2019 Part 2 of 3 HYDRATING SHEER LIP BALM SPF 30 - PINK BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN
avobenzone, octisalate, and homosalate lipstickProduct Information Item Code (Source) NDC:49358-565 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 30 mg in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50 mg in 1 g Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 100 mg in 1 g Inactive Ingredients Ingredient Name Strength Avocado Oil (UNII: 6VNO72PFC1) Shea Butter (UNII: K49155WL9Y) PARAFFIN (UNII: I9O0E3H2ZE) HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C) Castor Oil (UNII: D5340Y2I9G) OCTYLDODECANOL (UNII: 461N1O614Y) OLIVE OIL (UNII: 6UYK2W1W1E) HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) CORN OIL (UNII: 8470G57WFM) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) STEARIC ACID (UNII: 4ELV7Z65AP) SUNFLOWER OIL (UNII: 3W1JG795YI) SQUALANE (UNII: GW89575KF9) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBYL PALMITATE (UNII: QN83US2B0N) TOCOPHEROL (UNII: R0ZB2556P8) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 28 (UNII: 767IP0Y5NH) Product Characteristics Color PINK Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49358-565-01 4.2 g in 1 APPLICATOR; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 10/01/2019 Part 3 of 3 HYDRATING SHEER LIP BALM SPF 30 - NUDE BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN
avobenzone, octisalate, and homosalate lipstickProduct Information Item Code (Source) NDC:49358-566 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 30 mg in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50 mg in 1 g Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 100 mg in 1 g Inactive Ingredients Ingredient Name Strength Avocado Oil (UNII: 6VNO72PFC1) Shea Butter (UNII: K49155WL9Y) PARAFFIN (UNII: I9O0E3H2ZE) HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C) Castor Oil (UNII: D5340Y2I9G) OCTYLDODECANOL (UNII: 461N1O614Y) OLIVE OIL (UNII: 6UYK2W1W1E) HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) CORN OIL (UNII: 8470G57WFM) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) STEARIC ACID (UNII: 4ELV7Z65AP) SUNFLOWER OIL (UNII: 3W1JG795YI) SQUALANE (UNII: GW89575KF9) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBYL PALMITATE (UNII: QN83US2B0N) TOCOPHEROL (UNII: R0ZB2556P8) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 28 (UNII: 767IP0Y5NH) Product Characteristics Color BROWN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49358-566-01 4.2 g in 1 APPLICATOR; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 10/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 10/01/2019 Labeler - MDSolarSciences (013647301)
