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| Product NDC Code | 70412-818 | ||||
|---|---|---|---|---|---|
| Drug Name | Spf30 sunscreen and spf15 |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| Application Number | M020 | ||||
| Labeler Name | Zhejiang Ayan Biotech Co.,Ltd. | ||||
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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%, Homosalate 10%, Octocrylene10%, Octisalate 5% Purpose Sunscreen
Active Ingredients Avobenzone 3%, Homostate 10%, Octocrylene 10%, Octisalate 5% Purpose Sunscreen
Active Ingredients Avobenzone 2% Octocrylene 8% Octisalate 5.5% Homosalate 2% Purpose Sunscreen
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 Non-Water Resistant Product • Apply liberally 15 minutes before sun exposure • Use a water resistant sunscreen if swimming or sweating • Reapply at least every 2 hours • Children under 6 months: Ask a doctor Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. to 2 p.m. • Wear long sleeve shirts, pants, hats and sunglasses. Sun Protection Measures.
Directions Non-Water Resistant Product Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Children under 6 months: Ask a doctor Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures. •Limit time in the sun, especially from 10 a.m. to 2 p.m. •Wear long sleeve shirts, pants, hats and sunglasses.
Directions Apply liberally 15 minutes before sun exposure. Usa a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients. Water, Glycerin, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol, Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolymer, Bisabolol, Carbomer, Fragrance, Triethanolamine, Disodium EDTA
Inactive Ingredients Water, Glycerin, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol, Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolymer, Bisabolol, Carbomer, Fragrance, Triethanolamine, Disodium EDTA
Inactive Ingredients Mineral Oil, Ozokerite, Cera Microcristallina, Polyisobutene, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Polyethylene, Tridencyl Trimellitate, Butyrospermum Parkii (Shea Butter), BHT, Tocopheryl Acetate, 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
Uses Helps prevent sunburn
Uses Helps prevent sunburn.
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.SPF30 Sunscreen and SPF15 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE SPF30 Sunscreen Avobenzone, Homosalate, Octocrylene, Ocitsalate CETOSTEARYL ALCOHOL DIMETHICONE CAPRYLYL GLYCOL PHENOXYETHANOL GLYCERYL MONOSTEARATE VINYLPYRROLIDONE/HEXADECENE COPOLYMER LEVOMENOL CARBOXYPOLYMETHYLENE TROLAMINE EDETATE DISODIUM ANHYDROUS COCONUT AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE OCTISALATE OCTISALATE WATER GLYCERIN MEDIUM-CHAIN TRIGLYCERIDES POTASSIUM CETYL PHOSPHATE SPF15 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE MINERAL OIL CERESIN COCONUT OIL ETHYLHEXYL PALMITATE HIGH DENSITY POLYETHYLENE TRIDECYL TRIMELLITATE SHEA BUTTER BUTYLATED HYDROXYTOLUENE .ALPHA.-TOCOPHEROL ACETATE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE OCTISALATE OCTISALATE
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.Package Labeling: Kit
Package Labeling: 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.Drug Facts
Other information • Protect this product from excessive heat and direct sun
Drug Facts
Other information • Protect this product from excessive heat and direct sun
Drug Facts
Other Information Protect from excessive heat and direct sun.
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.
Do not use on damaged or broken skin.
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.
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 product is swallowed, get medical help or contact a Poison Control 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 AP Specialties
Questions? Call toll free
Questions? Call AP Specialties BATCH NO: Distributed by:
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.
Stop use and ask a doctor if rash occurs.
Stop use and ask a doctor if reash 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.
When using this product keep out of eyes. Rinse with water to remove.
When using this product keep out of eyes. Rinse with water to remove.
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: Spending time in the sun increases your risk of skin cancer or early skin aging. This product has been shown only to prevent sunburn skin cancer or early skin aging. This product is water resistant or sweat resistant. Skin Cancer/Skin Aging Alert: NOT NOT 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.
WARNINGS Spending time in the sun increases your risk of skin cnacer or early skin aging. this product has been shown only to prevent sunburn skin cancer or early skin aging. this product is water resistant or sweat resistant. Skin Cancer/Skin Aging Alert: NOT NOT 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.
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 reash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control 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