Label: ATTITUDE OCEANLY PHYTO-SUN TINTED OIL SPF 30- zinc oxide stick
- NDC Code(s): 61649-073-08, 61649-073-30
- 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.
- 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
Vitis Vinifera (Grape) Seed Oil, Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Wax, Coco-Caprylate/Caprate, Octyldodecanol, Helianthus Annuus (Sunflower) Seed Oil, Butyloctyl Salicylate, Mica, Polyhydroxystearic Acid, Cocos Nucifera (Coconut) Oil, Hydrolyzed Vegetable Protein, Glycogen (Zea Mays Phytoglycogen), CI 77492 (Iron Oxides), Tocopherol, CI 77491 (Iron Oxides), Silica, CI 77499 (Iron Oxides), Jojoba Esters, Trihydroxystearin, Ascophyllum Nodosum Extract, Crithmum Maritimum Extract, Fucus Vesiculosus (Bladderwrack) Extract, Laminaria Saccharina Extract, Plankton Extract, Ascorbyl Palmitate.
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INGREDIENTS AND APPEARANCE
ATTITUDE OCEANLY PHYTO-SUN TINTED OIL SPF 30
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61649-073 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 24 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCOGEN (UNII: 309GSC92U1) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) COCONUT OIL (UNII: Q9L0O73W7L) SUNFLOWER OIL (UNII: 3W1JG795YI) GRAPE SEED OIL (UNII: 930MLC8XGG) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) MICA (UNII: V8A1AW0880) CORN (UNII: 0N8672707O) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) JOJOBA OIL (UNII: 724GKU717M) SACCHARINA LATISSIMA (UNII: 68CMP2MB55) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ASCORBYL PALMITATE (UNII: QN83US2B0N) HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) FERRIC OXIDE RED (UNII: 1K09F3G675) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6) FUCUS VESICULOSUS (UNII: 535G2ABX9M) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) OCTYLDODECANOL (UNII: 461N1O614Y) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ) CRITHMUM MARITIMUM (UNII: J7IHY79BKY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61649-073-30 30 g in 1 CARTON; Type 0: Not a Combination Product 04/01/2024 2 NDC:61649-073-08 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(61649-073) , label(61649-073) , manufacture(61649-073) , pack(61649-073)