Label: ATTITUDE OCEANLY PHYTO-SUN LIP BALM SPF 30 TERRACOTTA- zinc oxide stick
- NDC Code(s): 61649-046-08
- Packager: 9055-7588 Quebec Inc. DBA Attitude
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 1, 2024
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Adults.
- Apply generously 15 minutes before sun exposure.
- Reapply at least every 2 hours, after eating or drinking.
- Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm; and wear long-sleeved shirts, pants, hats and sunglasses.
- Use a water resistant sunscreen if swimming or sweating.
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INACTIVE INGREDIENT
Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Polyhydroxystearic Acid, Helianthus Annuus (Sunflower) Seed Wax, Capryloyl Glycerin/Sebacic Acid Copolymer, Theobroma Cacao (Cocoa) Seed Butter, Helianthus Annuus (Sunflower) Seed Oil, Behenyl Behenate, C10-18 Triglycerides, C18-38 Alkyl Hydroxystearoyl Stearate, Pentadesma Butyracea Seed Butter, CI 77742 (Manganese Violet), CI 77491 (Iron Oxides), Euphorbia Cerifera (Candelilla) Wax, Hydrolyzed Vegetable Protein, Octyldodecanol, Glycogen (Zea Mays Phytoglycogen), CI 77499 (Iron Oxides), Tocopherol, Stearoyl Glutamic Acid, Jojoba Esters, Trihydroxystearin, Ascophyllum Nodosum Extract, Crithmum Maritimum Extract, Fucus Vesiculosus (Bladderwrack) Extract, Laminaria Saccharina Extract, Plankton Extract, Ascorbyl Palmitate.
- STORAGE AND HANDLING
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ATTITUDE OCEANLY PHYTO-SUN LIP BALM SPF 30 TERRACOTTA
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61649-046 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 g in 100 g Inactive Ingredients Ingredient Name Strength PENTADESMA BUTYRACEA WHOLE (UNII: 6F38M980TS) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) SUNFLOWER OIL (UNII: 3W1JG795YI) JOJOBA OIL (UNII: 724GKU717M) CRITHMUM MARITIMUM (UNII: J7IHY79BKY) SACCHARINA LATISSIMA (UNII: 68CMP2MB55) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) COCOA BUTTER (UNII: 512OYT1CRR) BEHENYL BEHENATE (UNII: K8NU647RJ0) CORN (UNII: 0N8672707O) GLYCOGEN (UNII: 309GSC92U1) FUCUS VESICULOSUS (UNII: 535G2ABX9M) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ) ASCORBYL PALMITATE (UNII: QN83US2B0N) CASTOR OIL (UNII: D5340Y2I9G) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) COCONUT OIL (UNII: Q9L0O73W7L) C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI) C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM) MANGANESE VIOLET (UNII: 72M48QQV8Q) HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL) OCTYLDODECANOL (UNII: 461N1O614Y) CANDELILLA WAX (UNII: WL0328HX19) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) STEAROYL GLUTAMIC ACID (UNII: 4R4O71786G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61649-046-08 8.5 g in 1 CARTON; Type 0: Not a Combination Product 04/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 04/01/2024 Labeler - 9055-7588 Quebec Inc. DBA Attitude (201137051) Establishment Name Address ID/FEI Business Operations 9055-7588 Quebec Inc. DBA Attitude 204307099 analysis(61649-046) , label(61649-046) , manufacture(61649-046) , pack(61649-046)
