Label: HYDRATING SHEER LIP BALM TRIO THE NEUTRALS BROAD SPECTRUM SPF 30- avobenzone, octisalate, and homosalate kit
- NDC Code(s): 49358-002-01
- Packager: MDSolarSciences
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 10, 2025
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- 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
- Reapply:
- use a water resistant sunscreen if swimming or sweating
- at least every 2 hours
- Children under 6 months: Ask a doctor
- Sun Protection Measures
:Spending time in the sun increases your risk of skin cancer and early skin aging.
To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection 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, Hydrogenated Soybean Oil, Paraffin, Ricinus Communis (Castor) Seed Oil, Olea Europaea (Olive) Fruit Oil, Octyldodecanol, Butyloctyl Salicylate, Hydrogenated Vegetable Oil, Jojoba Esters, Microcrystalline Wax, Stearic Acid, Helianthus Annuus (Sunflower) Seed Wax, Plant-Derived Squalane, Polyglycerin-3, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Ascorbyl Palmitate (Vitamin C), Tocopherol (Vitamin E), Rhus Verniciflua Peel Wax, Acacia Decurrens Flower Wax, Sorbitan Oleate, Synthetic Fluorphlogopite (Dream/Spice), May contain: CI 77891, CI 77491, CI 77492, CI 77499, CI 15850, CI 42090, CI 77861, CI 45410, CI 19140
- Company Information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDRATING SHEER LIP BALM TRIO THE NEUTRALS BROAD SPECTRUM SPF 30
avobenzone, octisalate, and homosalate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49358-002 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49358-002-01 1 in 1 CARTON; Type 0: Not a Combination Product 06/10/2025 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 CRYSTAL BROAD SPECTRUM SPF 30
avobenzone, octisalate, homosalate lipstickProduct Information Item Code (Source) NDC:49358-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CI 77491 (UNII: 1K09F3G675) CI 77492 (UNII: EX438O2MRT) CI 42090 (UNII: H3R47K3TBD) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) SHEA BUTTER (UNII: K49155WL9Y) CI 19140 (UNII: I753WB2F1M) OCTYLDODECANOL (UNII: 461N1O614Y) CI 77499 (UNII: XM0M87F357) CI 15850 (UNII: 481744AI4O) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) PARAFFIN (UNII: I9O0E3H2ZE) CI 77891 (UNII: 15FIX9V2JP) AVOCADO OIL (UNII: 6VNO72PFC1) CASTOR OIL (UNII: D5340Y2I9G) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) STEARIC ACID (UNII: 4ELV7Z65AP) HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV) RHUS VERNICIFLUA PEEL WAX (UNII: 6RG2461FCH) OLIVE OIL (UNII: 6UYK2W1W1E) ASCORBYL PALMITATE (UNII: QN83US2B0N) CI 45410 (UNII: 767IP0Y5NH) SQUALANE (UNII: GW89575KF9) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) TOCOPHEROL (UNII: R0ZB2556P8) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) SORBITAN OLEATE (UNII: 06XEA2VD56) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4.2 g in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/10/2025 Part 2 of 3 HYDRATING SHEER LIP BALM SPF 30 DREAM BROAD SPECTRUM SPF 30
avobenzone, octisalate, homosalate lipstickProduct Information Item Code (Source) NDC:49358-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CI 77491 (UNII: 1K09F3G675) CI 77492 (UNII: EX438O2MRT) CI 42090 (UNII: H3R47K3TBD) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) SHEA BUTTER (UNII: K49155WL9Y) CI 19140 (UNII: I753WB2F1M) OCTYLDODECANOL (UNII: 461N1O614Y) CI 77499 (UNII: XM0M87F357) CI 15850 (UNII: 481744AI4O) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) CI 77891 (UNII: 15FIX9V2JP) AVOCADO OIL (UNII: 6VNO72PFC1) CASTOR OIL (UNII: D5340Y2I9G) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) STEARIC ACID (UNII: 4ELV7Z65AP) HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV) RHUS VERNICIFLUA PEEL WAX (UNII: 6RG2461FCH) OLIVE OIL (UNII: 6UYK2W1W1E) ASCORBYL PALMITATE (UNII: QN83US2B0N) CI 45410 (UNII: 767IP0Y5NH) SQUALANE (UNII: GW89575KF9) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) TOCOPHEROL (UNII: R0ZB2556P8) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) SORBITAN OLEATE (UNII: 06XEA2VD56) MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M) PARAFFIN (UNII: I9O0E3H2ZE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4.2 g in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/10/2025 Part 3 of 3 HYDRATING SHEER LIP BALM SPF 30 SHIMMER BROAD SPECTRUM SPF 30
avobenzone, octisalate, homosalate lipstickProduct Information Item Code (Source) NDC:49358-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CI 77491 (UNII: 1K09F3G675) CI 77492 (UNII: EX438O2MRT) CI 42090 (UNII: H3R47K3TBD) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) SHEA BUTTER (UNII: K49155WL9Y) CI 19140 (UNII: I753WB2F1M) OCTYLDODECANOL (UNII: 461N1O614Y) CI 77499 (UNII: XM0M87F357) CI 15850 (UNII: 481744AI4O) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) CI 77891 (UNII: 15FIX9V2JP) AVOCADO OIL (UNII: 6VNO72PFC1) CASTOR OIL (UNII: D5340Y2I9G) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) STEARIC ACID (UNII: 4ELV7Z65AP) HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV) RHUS VERNICIFLUA PEEL WAX (UNII: 6RG2461FCH) OLIVE OIL (UNII: 6UYK2W1W1E) ASCORBYL PALMITATE (UNII: QN83US2B0N) CI 45410 (UNII: 767IP0Y5NH) SQUALANE (UNII: GW89575KF9) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) TOCOPHEROL (UNII: R0ZB2556P8) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) SORBITAN OLEATE (UNII: 06XEA2VD56) PARAFFIN (UNII: I9O0E3H2ZE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4.2 g in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/10/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/10/2025 Labeler - MDSolarSciences (013647301)
