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| Product NDC Code | 61649-179 | ||||
|---|---|---|---|---|---|
| Drug Name | Attitude oceanly phyto-sun kit spf 30 |
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| Type | Brand | ||||
| Route | TOPICAL | ||||
| Dosage Form | KIT | ||||
| Application Number | M020 | ||||
| Labeler Name | 9055-7588 Quebec Inc. DBA Attitude | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Zinc oxide (24 %)
Zinc oxide (24 %)
Zinc oxide (20 %)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
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.
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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
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.
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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Helps prevent sunburn.
Helps prevent sunburn.
Helps prevent sunburn.
Purpose
Information about the drug product’s indications for use.Sunscreen
Sunscreen
Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.ATTITUDE Oceanly Phyto-Sun Kit SPF 30 Zinc oxide ATTITUDE Oceanly Phyto-Sun Tinted Oil SPF 30 Zinc oxide FERROSOFERRIC OXIDE BUTYLOCTYL SALICYLATE JOJOBA OIL SACCHARINA LATISSIMA SILICON DIOXIDE OCTYLDODECANOL GRAPE SEED OIL MEDIUM-CHAIN TRIGLYCERIDES CRITHMUM MARITIMUM ASCORBYL PALMITATE CORN FERRIC OXIDE RED FUCUS VESICULOSUS ZINC OXIDE ZINC OXIDE GLYCOGEN POLYHYDROXYSTEARIC ACID (2300 MW) COCONUT OIL COCO-CAPRYLATE/CAPRATE SUNFLOWER OIL MICA FERRIC OXIDE YELLOW ALPHA-TOCOPHEROL HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) ASCOPHYLLUM NODOSUM HELIANTHUS ANNUUS SEED WAX HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) TRIHYDROXYSTEARIN ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby Rose Zinc oxide COCONUT OIL TRIHYDROXYSTEARIN BEHENYL BEHENATE C18-38 ALKYL HYDROXYSTEAROYL STEARATE CANDELILLA WAX SUNFLOWER OIL MANGANESE VIOLET HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) .ALPHA.-TOCOPHEROL MEDIUM-CHAIN TRIGLYCERIDES POLYHYDROXYSTEARIC ACID (2300 MW) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) GLYCOGEN STEAROYL GLUTAMIC ACID PENTADESMA BUTYRACEA WHOLE C10-18 TRIGLYCERIDES OCTYLDODECANOL CORN FERRIC OXIDE RED CRITHMUM MARITIMUM HELIANTHUS ANNUUS SEED WAX ASCOPHYLLUM NODOSUM FUCUS VESICULOSUS SACCHARINA LATISSIMA ASCORBYL PALMITATE HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) COCOA BUTTER JOJOBA OIL ZINC OXIDE ZINC OXIDE CASTOR OIL ATTITUDE Oceanly Phyto-Sun Tinted Shimmer Cream SPF 30 Zinc oxide ASCOPHYLLUM NODOSUM HELIANTHUS ANNUUS SEED WAX BUTYLOCTYL SALICYLATE POLYHYDROXYSTEARIC ACID (2300 MW) MICA JOJOBA OIL POLYGLYCERIN-3 ZINC OXIDE ZINC OXIDE SUNFLOWER OIL MEDIUM-CHAIN TRIGLYCERIDES FERRIC OXIDE YELLOW .ALPHA.-TOCOPHEROL SILICON DIOXIDE CRITHMUM MARITIMUM PROPANEDIOL SACCHARINA LATISSIMA THALLUS COCONUT OIL HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) CALCIUM CHLORIDE ACACIA DECURRENS FLOWER WAX OCTYLDODECANOL BISMUTH OXYCHLORIDE HYDROGENATED SOYBEAN LECITHIN TRIHYDROXYSTEARIN FUCUS VESICULOSUS GLYCOGEN FERRIC OXIDE RED ASCORBYL PALMITATE HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) CORN GRAPE SEED OIL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.ATTITUDE Oceanly SPF 30 Broad spectrum sunscreen SPF 30 Mineral-based sunscreen with non-nano zinc oxide Vegan EWG Verified Phyto-sun Tinted oil + Tinted shimmer cream + Baby Rose Lip Balm (3 x 0.3 oz) Plastic free skincare SPF 30 NPN 80125380 / NPN 80125355 / NPN 80125337 SUN For a protected skin Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.ATTITUDE Oceanly Phyto-sun Tinted Shimmer Cream SPF 30 DRUG FACTS Zinc oxide (24 %) Sunscreen Helps prevent sunburn. For external use only. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not use on broken skin. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and consult a doctor if rash occurs. 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. Store at temperatures < 90F and protect from direct sun. Avoid contact of packaging with water. Questions ? 1-855-509-7225
ATTITUDE Oceanly Phyto-sun Tinted Oil SPF 30 DRUG FACTS Zinc oxide (24 %) Sunscreen Helps prevent sunburn. For external use only. Do not use on broken skin. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and consult a doctor if rash occurs. 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. Store at temperatures < 90F and protect from direct sun. Avoid contact of packaging with water. Questions ? 1-855-509-7225
ATTITUDE Oceanly Phyto-sun Lip Balm SPF 30 Baby Rose DRUG FACTS Zinc oxide (20 %) Sunscreen Helps prevent sunburn. For external use only. Do not use on broken skin. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and consult a doctor if rash occurs. 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. Store at temperatures < 90F and protect from direct sun. Avoid contact of packaging with water. Questions ? 1-855-509-7225
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on broken skin.
Do not use on broken skin.
Do not use on broken skin.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions ? 1-855-509-7225
Questions ? 1-855-509-7225
Questions ? 1-855-509-7225
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and consult a doctor if rash occurs.
Stop use and consult a doctor if rash occurs.
Stop use and consult a doctor if rash occurs.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Storage and handling
Information about safe storage and handling of the drug product.Store at temperatures < 90F and protect from direct sun. Avoid contact of packaging with water.
Store at temperatures < 90F and protect from direct sun. Avoid contact of packaging with water.
Store at temperatures < 90F and protect from direct sun. Avoid contact of packaging with water.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.For external use only. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not use on broken skin. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and consult a doctor if rash occurs.
For external use only. Do not use on broken skin. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and consult a doctor if rash occurs.
For external use only. Do not use on broken skin. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and consult a doctor if rash occurs.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API