Label: ATTITUDE OCEANLY PHYTO-SUN LIP BALM SPF 30 PEACHY SHELL- zinc oxide stick
- NDC Code(s): 61649-047-08
- 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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- Official Label (Printer Friendly)
- 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
Cocos Nucifera (Coconut) Oil, Caprylic/Capric Triglyceride, 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 77491 (Iron Oxides), Octyldodecanol, Euphorbia Cerifera (Candelilla) Wax, CI 77492 (Iron Oxides), Hydrolyzed Vegetable Protein, Glycogen (Zea Mays Phytoglycogen), Tocopherol, 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 PEACHY SHELL
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61649-047 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 COCONUT OIL (UNII: Q9L0O73W7L) C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI) C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM) HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL) OCTYLDODECANOL (UNII: 461N1O614Y) PENTADESMA BUTYRACEA WHOLE (UNII: 6F38M980TS) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) BEHENYL BEHENATE (UNII: K8NU647RJ0) FERRIC OXIDE RED (UNII: 1K09F3G675) CASTOR OIL (UNII: D5340Y2I9G) SUNFLOWER OIL (UNII: 3W1JG795YI) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CANDELILLA WAX (UNII: WL0328HX19) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) JOJOBA OIL (UNII: 724GKU717M) SACCHARINA LATISSIMA (UNII: 68CMP2MB55) COCOA BUTTER (UNII: 512OYT1CRR) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ) ASCORBYL PALMITATE (UNII: QN83US2B0N) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6) CRITHMUM MARITIMUM (UNII: J7IHY79BKY) CORN (UNII: 0N8672707O) GLYCOGEN (UNII: 309GSC92U1) FUCUS VESICULOSUS (UNII: 535G2ABX9M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61649-047-08 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(61649-047) , label(61649-047) , manufacture(61649-047) , pack(61649-047)
