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Allies of skin the one spf-50 invisible sunscreen - Medication Information

Product NDC Code 83852-438
Drug Name

Allies of skin the one spf-50 invisible sunscreen

Type Brand
Active Ingredients
Avobenzone 30 mg/ml
Homosalate 70 mg/ml
Octisalate 50 mg/ml
Octocrylene 100 mg/ml
Route TOPICAL
Dosage Form GEL
Application Number M020
Labeler Name ALLIES GROUP PTE. LTD.
Packages
Package NDC Code Description
83852-438-03 3 ml in 1 packet (83852-438-03)
83852-438-20 1 tube in 1 box (83852-438-20) / 20 ml in 1 tube
83852-438-50 1 tube in 1 box (83852-438-50) / 50 ml in 1 tube
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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 feeding
If 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