Label: TINTED LIP CREAM SPF 15- zinc oxide cream
- NDC Code(s): 68577-168-01
- Packager: COSMAX USA, CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 13, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
-
DIRECTIONS
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
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INACTIVE INGREDIENT
Inactive ingredients:
Hydrogenated Polydecene, Diisostearyl Malate, Ozokerite, Synthetic Wax, Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Butyloctyl Salicylate, Tridecyl Trimellitate, Bis-Diglyceryl Polyacyladipate-2, Pentaerylhrityl Tetraisostearate, Polyglyceryl-4 Isostearate, Dimer Dilinoleyl Dimer Dilinoleate, Diglyceryl Sebacate/lsopalmitate*, Moringa Oil/Hydrogenated Moringa Oil Esters, Polyhydroxystearic Acid, Silica, Caprae Lac (Goat Milk), Tocopherol (Vitamin E), Kaolin, Hydrogenated Vegetable Oil, Quercetin, Oleic/Linoleic/Linolenic Polyglycerides, Poly C10-30 Alkyl Acrylate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-2 Triisostearate, Stearalkonium Hectorite, Propylene Carbonate, Dehydroacetic Acid, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Iron Oxides (CI 77492), Titanium Dioxide (CI 77891), Carmine (CI 75470).
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TINTED LIP CREAM SPF 15
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68577-168 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9.28 mg in 100 mg Inactive Ingredients Ingredient Name Strength POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) PROPYLENE CARBONATE (UNII: 8D08K3S51E) KAOLIN (UNII: 24H4NWX5CO) DEHYDROACETIC ACID (UNII: 2KAG279R6R) DIMER DILINOLEYL DIMER DILINOLEATE (UNII: 0E2D5DBT7M) DIGLYCERYL SEBACATE/ISOPALMITATE (UNII: XK79T95N8Z) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) GOAT MILK (UNII: XE5K5I4RP7) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) TOCOPHEROL (UNII: R0ZB2556P8) CORN OIL (UNII: 8470G57WFM) SYNTHETIC WAX (540 MW) (UNII: DW2TC44JRY) HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529) CERESIN (UNII: Q1LS2UJO3A) QUERCETIN (UNII: 9IKM0I5T1E) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) IRON OXIDES (UNII: 1K09F3G675) BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T) PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U) ETHYLHEXYL PALMITATE (UNII: 2865993309) SILICA (UNII: ETJ7Z6XBU4) BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68577-168-01 1 in 1 CARTON 01/01/2024 1 17 mg in 1 TUBE, WITH 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 01/01/2024 Labeler - COSMAX USA, CORPORATION (010990210) Registrant - COSMAX USA, CORPORATION (010990210) Establishment Name Address ID/FEI Business Operations COSMAX USA, CORPORATION 010990210 manufacture(68577-168)
