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| Product NDC Code | 77365-009 | ||||
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| Drug Name | Daily defender mineral sunscreen broad spectrum spf 50 water resistant (80 minutes) |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Thrive Causemetics | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Zinc Oxide 19.0%
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.Directions For sunscreen use: Apply liberally 15 minutes before sun exposure. reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours. Children under 6 months of age: Ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 am. - 2 pm. Wear long-sleeved shirts, pants, and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients AQUA/WATER/EAU, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIISOOCTYL SUCCINATE, PROPANEDIOL, BUTYLOCTYL SALICYLATE, DICAPRYLYL CARBONATE, NIACINAMIDE, GLYCERIN, ETHYLHEXYL METHOXYCRYLENE, POLYMETHYLSILSESQUIOXANE, CETEARYL OLIVATE, MAGNESIUM ALUMINUM SILICATE, POLYHYDROXYSTEARIC ACID, TERMINALIA FERDINANDIANA FRUIT EXTRACT, VACCINIUM VITIS-IDAEA FRUIT EXTRACT, PONGAMIA PINNATA SEED EXTRACT, MALEATED SOYBEAN OIL GLYCERYL/OCTYLDODECANOL ESTERS, ECTOIN, ALOE BARBADENSIS LEAF JUICE, SODIUM HYALURONATE, ASCORBYL TETRAISOPALMITATE, MENTHYL LACTATE, JOJOBA ESTERS, TRIETHOXYCAPRYLYLSILANE, ARACHIDYL ALCOHOL, SILICA, LAUROYL LYSINE, POTASSIUM CETYL PHOSPHATE, POLYGLYCERYL-4 LAURATE/SUCCINATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISONONYL ISONONANOATE, OCTYLDODECANOL, ETHYLENE/PROPYLENE/STYRENE COPOLYMER, POLYGLUTAMIC ACID, SORBITAN OLEATE, TRIHYDROXYSTEARIN, ARACHIDYL GLUCOSIDE, SORBITAN OLIVATE, BEHENYL ALCOHOL, XANTHAN GUM, GLUCONOLACTONE, CALCIUM GLUCONATE, TETRASODIUM GLUTAMATE DIACETATE, CITRIC ACID, SODIUM BENZOATE, ETHYLHEXYLGLYCERIN, CAPRYLYL GLYCOL, PHENOXYETHANOL, [+/- TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499)].
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.Uses Helps prevent sunburn If used as directed with other sun protection measures ( see Directions ), decreases the risk Skin cancer and early skin aging caused by the sun.
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Daily Defender Mineral Sunscreen Broad Spectrum SPF 50 Water Resistant (80 minutes) Zinc Oxide Zinc Oxide ZINC CATION WATER MEDIUM-CHAIN TRIGLYCERIDES DIISOBUTYL SUCCINATE PROPANEDIOL BUTYLOCTYL SALICYLATE DICAPRYLYL CARBONATE NIACINAMIDE GLYCERIN ETHYLHEXYL METHOXYCRYLENE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) CETEARYL OLIVATE MAGNESIUM ALUMINUM SILICATE POLYHYDROXYSTEARIC ACID (2300 MW) KAKADU PLUM LINGONBERRY PONGAMIA PINNATA SEED SOYBEAN OIL GLYCERETH-8 ESTERS ECTOINE ALOE VERA LEAF HYALURONATE SODIUM ASCORBYL TETRAISOPALMITATE MENTHYL LACTATE, (-)- JOJOBA OIL, RANDOMIZED TRIETHOXYCAPRYLYLSILANE ARACHIDYL ALCOHOL SILICON DIOXIDE LAUROYL LYSINE POTASSIUM CETYL PHOSPHATE POLYGLYCERYL-4 LAURATE/SUCCINATE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) ISONONYL ISONONANOATE OCTYLDODECANOL STYRENE/ISOPRENE COPOLYMER (28:72; 210000 MW) POLYGLUTAMIC ACID (8000 MW) SORBITAN MONOOLEATE TRIHYDROXYSTEARIN ARACHIDYL GLUCOSIDE SORBITAN OLIVATE DOCOSANOL XANTHAN GUM GLUCONOLACTONE CALCIUM GLUCONATE TETRASODIUM GLUTAMATE DIACETATE CITRIC ACID MONOHYDRATE SODIUM BENZOATE ETHYLHEXYLGLYCERIN CAPRYLYL GLYCOL PHENOXYETHANOL TITANIUM DIOXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE
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.PRINCIPAL DISPLAY PANEL - 50 mL Tube Box bigger than beauty ® SKINCARE DERMATOLOGIST RECOMMENDED DAILY DEFENDER™ MINERAL SUNSCREEN Broad Spectrum SPF 50 Barrier Power Boost™ Water Resistant (80 minutes) UNTINTED 1.7 fl oz / 50 mL Principal Display Panel - 50 mL Tube Box
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.Drug Facts
Dist. by Thrive Causemetics, Inc. Los Angeles, CA 90045
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 damaged or 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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call (888) 804-4318 or visit www.thrivecausemetics.com
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 ask 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 keep out of eyes. Rinse with water to remove.
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect this product in this container from excessive heat and direct sun.
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.Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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