Label: ATTITUDE OCEANLY PHYTO-SUN KIT SPF 30- zinc oxide kit
- NDC Code(s): 61649-045-08, 61649-071-08, 61649-073-08, 61649-179-01
- 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)
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ATTITUDE Oceanly Phyto-sun Tinted Shimmer Cream SPF 30
DRUG FACTS
For external use only.
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.
Vitis Vinifera (Grape) Seed Oil, Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Wax, Propanediol, Mica, Butyloctyl Salicylate, Jojoba Esters, CI 77163 (Bismuth Oxychloride), Polyhydroxystearic Acid, Cocos Nucifera (Coconut) Oil, CI 77492 (Iron Oxides), Helianthus Annuus (Sunflower) Seed Oil, Octyldodecanol, Hydrolyzed Vegetable Protein, Glycogen (Zea Mays Phytoglycogen), CI 77491 (Iron Oxides), Acacia Decurrens Flower Wax, Polyglycerin-3, Tocopherol, Silica, Hydrogenated Lecithin, Trihydroxystearin, Calcium Chloride, Ascophyllum Nodosum Extract, Crithmum Maritimum Extract, Fucus Vesiculosus (Bladderwrack) Extract, Laminaria Saccharina Extract, Plankton Extract, Ascorbyl Palmitate.
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ATTITUDE Oceanly Phyto-sun Tinted Oil SPF 30
DRUG FACTS
For external use only.
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.
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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ATTITUDE Oceanly Phyto-sun Lip Balm SPF 30 Baby Rose
DRUG FACTS
For external use only.
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.
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 77742 (Manganese Violet), Euphorbia Cerifera (Candelilla) Wax, CI 77491 (Iron Oxides), Hydrolyzed Vegetable Protein, Glycogen (Zea Mays Phytoglycogen), Octyldodecanol, Tocopherol, Stearoyl Glutamic Acid, Jojoba Esters, Trihydroxystearin, Ascophyllum Nodosum Extract, Crithmum Maritimum Extract, Fucus Vesiculosus (Bladderwrack) Extract, Laminaria Saccharina Extract, Plankton Extract, Ascorbyl Palmitate.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ATTITUDE OCEANLY PHYTO-SUN KIT SPF 30
zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61649-179 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61649-179-01 1 in 1 CARTON; Type 0: Not a Combination Product 04/01/2024 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 CARTON 8.5 g Part 2 1 CARTON 8.5 g Part 3 1 CARTON 8.5 g Part 1 of 3 ATTITUDE OCEANLY PHYTO-SUN TINTED OIL SPF 30
zinc oxide stickProduct Information 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 FERROSOFERRIC OXIDE (UNII: XM0M87F357) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) JOJOBA OIL (UNII: 724GKU717M) SACCHARINA LATISSIMA (UNII: 68CMP2MB55) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) OCTYLDODECANOL (UNII: 461N1O614Y) GRAPE SEED OIL (UNII: 930MLC8XGG) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CRITHMUM MARITIMUM (UNII: J7IHY79BKY) ASCORBYL PALMITATE (UNII: QN83US2B0N) CORN (UNII: 0N8672707O) FERRIC OXIDE RED (UNII: 1K09F3G675) FUCUS VESICULOSUS (UNII: 535G2ABX9M) GLYCOGEN (UNII: 309GSC92U1) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) COCONUT OIL (UNII: Q9L0O73W7L) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) SUNFLOWER OIL (UNII: 3W1JG795YI) MICA (UNII: V8A1AW0880) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL) ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61649-073-08 8.5 g in 1 CARTON; 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 04/01/2024 Part 2 of 3 ATTITUDE OCEANLY PHYTO-SUN LIP BALM SPF 30 BABY ROSE
zinc oxide stickProduct Information Item Code (Source) NDC:61649-045 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) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) BEHENYL BEHENATE (UNII: K8NU647RJ0) C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM) CANDELILLA WAX (UNII: WL0328HX19) SUNFLOWER OIL (UNII: 3W1JG795YI) MANGANESE VIOLET (UNII: 72M48QQV8Q) HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) GLYCOGEN (UNII: 309GSC92U1) STEAROYL GLUTAMIC ACID (UNII: 4R4O71786G) PENTADESMA BUTYRACEA WHOLE (UNII: 6F38M980TS) C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI) OCTYLDODECANOL (UNII: 461N1O614Y) CORN (UNII: 0N8672707O) FERRIC OXIDE RED (UNII: 1K09F3G675) CRITHMUM MARITIMUM (UNII: J7IHY79BKY) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ) FUCUS VESICULOSUS (UNII: 535G2ABX9M) SACCHARINA LATISSIMA (UNII: 68CMP2MB55) ASCORBYL PALMITATE (UNII: QN83US2B0N) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6) COCOA BUTTER (UNII: 512OYT1CRR) JOJOBA OIL (UNII: 724GKU717M) CASTOR OIL (UNII: D5340Y2I9G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61649-045-08 8.5 g in 1 CARTON; 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 03/15/2024 Part 3 of 3 ATTITUDE OCEANLY PHYTO-SUN TINTED SHIMMER CREAM SPF 30
zinc oxide stickProduct Information Item Code (Source) NDC:61649-071 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 ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) MICA (UNII: V8A1AW0880) JOJOBA OIL (UNII: 724GKU717M) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) SUNFLOWER OIL (UNII: 3W1JG795YI) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CRITHMUM MARITIMUM (UNII: J7IHY79BKY) PROPANEDIOL (UNII: 5965N8W85T) SACCHARINA LATISSIMA THALLUS (UNII: 68CMP2MB55) COCONUT OIL (UNII: Q9L0O73W7L) HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL) CALCIUM CHLORIDE (UNII: M4I0D6VV5M) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) OCTYLDODECANOL (UNII: 461N1O614Y) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) FUCUS VESICULOSUS (UNII: 535G2ABX9M) GLYCOGEN (UNII: 309GSC92U1) FERRIC OXIDE RED (UNII: 1K09F3G675) ASCORBYL PALMITATE (UNII: QN83US2B0N) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6) CORN (UNII: 0N8672707O) GRAPE SEED OIL (UNII: 930MLC8XGG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61649-071-08 8.5 g in 1 CARTON; 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 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(61649-179) , label(61649-179) , manufacture(61649-179) , pack(61649-179)
