Label: SUNPROOF NOURISHING LIP BALM BROAD SPECTRUM SPF 24 SUNSCREEN FRESH MINT- avobenzone, homosalate, and octisalate lipstick
- NDC Code(s): 77365-007-01
- Packager: Thrive Causemetics
- 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 September 14, 2023
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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 Skin cancer and early skin aging caused by the sun.
- Warnings
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Directions
For sunscreen use:
- Apply liberally 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Use a water resistant sunscreen if swimming or sweating.
- Children under 6 months of age: Ask a doctor.
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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 am. - 2 pm.
- Wear long-sleeved shirts, pants, and sunglasses.
- Other information
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Inactive ingredients
SYNTHETIC BEESWAX, POLYHYDROXYSTEARIC ACID, THEOBROMA CACAO (COCOA) SEED BUTTER, BUTYROSPERMUM PARKII (SHEA) BUTTER, BUTYLOCTYL SALICYLATE, C32-36 ISOALKYL STEARATE, ALUMINUM STARCH OCTENYLSUCCINATE, BIS-DIGLYCERYL POLYACYLADIPATE-2, BEHENYL BEHENATE, MENTHA PIPERITA (PEPPERMINT) OIL, EUPHORBIA CERIFERA (CANDELILLA) WAX (CANDELILLA CERA), STEARYL BEHENATE, CETEARYL ALCOHOL, PUNICA GRANATUM STEROLS, ARGANIA SPINOSA KERNEL OIL, POLYGLYCERYL-3 STEARATE, MENTHA VIRIDIS (SPEARMINT) LEAF OIL, PIMPINELLA ANISUM (ANISE) SEED OIL, PANTHENOL (VITAMIN B5), SODIUM HYALURONATE, MAGNESIUM ASPARTATE, ZINC GLUCONATE, MANGIFERA INDICA (MANGO) SEED BUTTER, PASSIFLORA INCARNATA SEED OIL, COPPER GLUCONATE, PRUNUS AVIUM (SWEET CHERRY) SEED OIL, POLYSORBATE 60, RICINUS COMMUNIS (CASTOR) SEED OIL, STEVIA REBAUDIANA EXTRACT, HYDROGENATED CASTOR OIL, LIMONENE
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 8 g Tube Box
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INGREDIENTS AND APPEARANCE
SUNPROOF NOURISHING LIP BALM BROAD SPECTRUM SPF 24 SUNSCREEN FRESH MINT
avobenzone, homosalate, and octisalate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77365-007 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 Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 100 mg in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50 mg in 1 g Inactive Ingredients Ingredient Name Strength SYNTHETIC BEESWAX (UNII: 08MNR5YE2R) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) COCOA BUTTER (UNII: 512OYT1CRR) SHEA BUTTER (UNII: K49155WL9Y) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) C32-36 ISOALKYL STEARATE (UNII: TR62N75RCU) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T) BEHENYL BEHENATE (UNII: K8NU647RJ0) PEPPERMINT OIL (UNII: AV092KU4JH) CANDELILLA WAX (UNII: WL0328HX19) STEARYL BEHENATE (UNII: A68S9UI39D) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PUNICA GRANATUM STEROLS (UNII: UKV92KC49T) ARGAN OIL (UNII: 4V59G5UW9X) POLYGLYCERYL-3 STEARATE (UNII: 8FDA8C98S3) SPEARMINT OIL (UNII: C3M81465G5) ANISE OIL (UNII: 6Y89129C8H) PANTHENOL (UNII: WV9CM0O67Z) HYALURONATE SODIUM (UNII: YSE9PPT4TH) MAGNESIUM ASPARTATE (UNII: R17X820ROL) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) PASSIFLORA INCARNATA SEED OIL (UNII: S0SU5AC95J) COPPER GLUCONATE (UNII: RV823G6G67) SWEET CHERRY SEED OIL (UNII: 9X3RP3RJFH) POLYSORBATE 60 (UNII: CAL22UVI4M) CASTOR OIL (UNII: D5340Y2I9G) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) LIMONENE, (+)- (UNII: GFD7C86Q1W) Product Characteristics Color YELLOW Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77365-007-01 1 in 1 BOX 04/19/2023 1 8 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/19/2023 Labeler - Thrive Causemetics (039299574) Establishment Name Address ID/FEI Business Operations PhytogenX, Inc. 624386772 MANUFACTURE(77365-007)
