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| Product NDC Code | 80782-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Day in the sun kit |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| Application Number | part352 | ||||
| Labeler Name | THE WONDERFUL GROUP LLC | ||||
| 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.Active ingredients Avobenzone 3.0% Homosalate 8.0% Octisalate 5.0% Octocrylene 8.0%
Active ingredients Avobenzone 3.00% Homosalate 9.0% Octisalate 5.0% Octocrylene 9.0%
Active ingredients Avobenzone 3.0% Homosalate 8.0% Octisalate 5.0% Octocrylene 8.0%
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 apply liberally and evenly 15 minutes before sun exposure 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 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating
Directions apply liberally and evenly 15 minutes before sun exposure 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 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating
Directions apply liberally and evenly 15 minutes before sun exposure 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 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Butylene Glycol Dicaprylate/Dicaprate, Butyloctyl Salicylate, Propylene Glycol, PEG-100 Stearate,VP/Eicosene Copolymer, Acrylates Copolymer, Steareth-20,Glyceryl Stearate, Steareth-2, Fragrance, Phenoxyethanol,Ethylhexylglycerin, Acrylates/C1 0-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Sodium Hyaluronate,Sodium Hydroxide,fragrance
Inactive ingredients Water, Vilis Vinifara Seed Oil, Butyloctyl Salicylate, Cocos Nucifera Oil, Glyceryl Stearate, Butylene Glycol Dicaprylate/Dicaprate, Aloe Barbadensis Leaf Extract, VP/Eicosene Copolymer, Acrylates Copolymer, Cetearyl Alcohol,Steareth-20, Steareth-2, Fragrance, Trehalose, Sodium PCA,Prunus Persica(Peach)Resin ExTract, DendrobiumCandidum Stem Extract, Tremella Fuciformis Sporocarp Extract, Cistanche Deserticola Extract, Phenoxyethanol,Ethylhexylglycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hyaluronate,TocopheryiAcetate,Sodium Hydroxide,fragrance
Inactive ingredients Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Ceresine,Microcrystalline Wax, Hydrogenated Vegetable Oil,Hydrogenated Soybean Oil, Olea Europaea Fruit Oil,Butyrospermum Parkii Butter, VP/Eicosene Copolymer,fragrance
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 of skin cancer and early skin aging caused by the sun
Uses helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun”
Uses helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen
Purpose Sunscreen
Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Day in the sun kit AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE SUNSCREEN BROAD SPECTRUM SPF 30 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE WATER BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE BUTYLOCTYL SALICYLATE PROPYLENE GLYCOL PEG-100 STEARATE VINYLPYRROLIDONE/EICOSENE COPOLYMER BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) STEARETH-20 GLYCERYL MONOSTEARATE STEARETH-2 PHENOXYETHANOL ETHYLHEXYLGLYCERIN CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) EDETATE DISODIUM ANHYDROUS HYALURONATE SODIUM SODIUM HYDROXIDE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE Sunscreen Moisturizing Face Broad Spectrum SPF 40 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE WATER GRAPE SEED OIL BUTYLOCTYL SALICYLATE COCONUT OIL GLYCERYL MONOSTEARATE ALOE VERA LEAF VINYLPYRROLIDONE/EICOSENE COPOLYMER CETOSTEARYL ALCOHOL TREHALOSE SODIUM PYRROLIDONE CARBOXYLATE PRUNUS PERSICA TWIG DENDROBIUM MONILIFORME WHOLE TREMELLA FUCIFORMIS FRUITING BODY CISTANCHE DESERTICOLA STEM PHENOXYETHANOL ETHYLHEXYLGLYCERIN CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) HYALURONATE SODIUM .ALPHA.-TOCOPHEROL ACETATE BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) STEARETH-20 STEARETH-2 SODIUM HYDROXIDE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE SUNSCREEN LIP BALM BROAD SPECTRUM SPF 30 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE ETHYLHEXYL PALMITATE MEDIUM-CHAIN TRIGLYCERIDES SODIUM DICHLOROACETATE MICROCRYSTALLINE WAX CANOLA OIL HYDROGENATED SOYBEAN OIL OLIVE OIL BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES VINYLPYRROLIDONE/EICOSENE COPOLYMER AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE Aloe Gel Aftersun Lotion
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.image description image description image description
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 for Sunscreen Lotion Broad Spectrum SPF 30
Other information protect the product in this container from excessive heat and direct sun
Drug Facts for Sunscreen Moisturizing Face Cream Broad Spectrum SPF 40
Other information protect the product in this container from excessive heat and direct sun
Drug Facts for Sunscreen Lip Balm Broad Spectrum SPF 30
Other information protect the 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 irritation or rash develops Keep out of reach of children . If product is swallowed, get medical attention or contact Poison Control Center immediately.
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 irritation or rash develops Keep out of reach of children . If a product is swallowed, get medical attention or contact a Poison Control Center immediately.
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 irritation or rash develops Keep out of reach of children. If product is swallowed, get medical attention or contact Poison Control Center immediately.
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