Label: ATTITUDE OCEANLY PHYTO-SUN TINTED CREAM SPF 30- zinc oxide stick
- NDC Code(s): 61649-070-30
- 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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- 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.
- 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, Propanediol, Butyloctyl Salicylate, Jojoba Esters, Mica, Polyhydroxystearic Acid, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Hydrolyzed Vegetable Protein, Glycogen (Zea Mays Phytoglycogen), Acacia Decurrens Flower Wax, Polyglycerin-3, CI 77492 (Iron Oxides), Octyldodecanol, Tocopherol, CI 77491 (Iron Oxides), Silica, CI 77499 (Iron Oxides), 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 TINTED CREAM SPF 30
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61649-070 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 POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) OCTYLDODECANOL (UNII: 461N1O614Y) HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) SUNFLOWER OIL (UNII: 3W1JG795YI) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6) GLYCOGEN (UNII: 309GSC92U1) FUCUS VESICULOSUS (UNII: 535G2ABX9M) PROPANEDIOL (UNII: 5965N8W85T) JOJOBA OIL (UNII: 724GKU717M) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GRAPE SEED OIL (UNII: 930MLC8XGG) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) COCONUT OIL (UNII: Q9L0O73W7L) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) FERRIC OXIDE RED (UNII: 1K09F3G675) CORN (UNII: 0N8672707O) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CRITHMUM MARITIMUM (UNII: J7IHY79BKY) SACCHARINA LATISSIMA (UNII: 68CMP2MB55) ASCORBYL PALMITATE (UNII: QN83US2B0N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61649-070-30 30 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(61649-070) , label(61649-070) , manufacture(61649-070) , pack(61649-070)
