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| Product NDC Code | 83852-438 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Allies of skin the one spf-50 invisible sunscreen |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | GEL | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | ALLIES GROUP PTE. LTD. | ||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Avobenzone 3.00%, Homosalate 7.00%, Octocrylene 10.00%, Octisalate 5.00% 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: • Apply liberally 15 minutes before sun exposure and as needed. • children under 6 months of age: ask a doctor.Reapply:• after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 broad spectrum SPF 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Isododecane, Dimethicone/bis-lsobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Tridecyl Salicylate, Aloe Barbadensis Leaf Extract, Camellia Sinensis (Green Tea) Extract, Citrullus Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Extract, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Punica Granatum (Pomegranate) Extract, Rosmarinus Officinalis (Rosemary) Extract, Rubus Idaeus (Raspberry) Oil, Niacinamide, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopherol (Vitamin E)
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. • Higher SPF gives sunburn protection. • 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
Spl product data elements
Usually a list of ingredients in a drug product.ALLIES OF SKIN The One SPF-50 Invisible Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE ISODODECANE DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER BUTYLOCTYL SALICYLATE MEDIUM-CHAIN TRIGLYCERIDES TRIDECYL SALICYLATE ALOE VERA LEAF GREEN TEA LEAF WATERMELON CARROT GLYCYRRHIZA GLABRA HELIANTHUS ANNUUS FLOWERING TOP PUNICA GRANATUM ROOT BARK ROSEMARY NIACINAMIDE TETRAHEXYLDECYL ASCORBATE TOCOPHEROL 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:50ml Outer Package Inner Package
Package Labeling:3ml Label
Package Labeling: 20ml Outer Package02 Inner Package02
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 in this container 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.
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.
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 or irritation develops and lasts.
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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
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 or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.
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