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Sea and c sheer face serum - Medication Information

Product NDC Code 61197-216
Drug Name

Sea and c sheer face serum

Type Brand
Active Ingredients
Avobenzone 2.9 g/100ml
Homosalate 9.8 g/100ml
Octisalate 4.9 g/100ml
Octocrylene 9.5 g/100ml
Route TOPICAL
Dosage Form LIQUID
Application Number M020
Labeler Name Pacifica Beauty, LLC
Packages
Package NDC Code Description
61197-216-00 50 ml in 1 bottle, pump (61197-216-00)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Avobenzone 2.9% Sunscreen Homosalate 9.8% Sunscreen Octisalate 4.9% Sunscreen Octocrylene 9.5% 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 Shake well. Apply liberally 15 minutes before sun exposure. Use water resistant sunscreen if swimming or sweating. Reapply after swimming or sweating. Reapply at least every 2 hours. Sun protection measures. Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher & other sun protection measures including: - limit time in the sun, especially from 10 a.m. - 2 p.m. - wear long-sleeve shirts, pants, hats & sunglasses. Children under 6 months: ask a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients: Aqua, Butyloctyl Salicylate, Coconut Alkanes, Calcium Sodium Borosilicate, Cetearyl Alcohol, Parfum (Natural), Propanediol, Ascorbate (Vitamin C), Tocopherol (Vitamin E), Ascophyllum Nodosum (Kelp) Extract, Algae Extract, Withania Somnifera (Ashwagandha) Root Extract, Aloe Barbadensis Leaf Juice, Caffeine, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Coco Caprylate/ Caprate, Coco-Glucoside, Ethyl Ferulate, Fructose, Glycerin, Glyceryl Stearate, Lauroyl Lysine, Microcrystalline Cellulose, Sodium Gluconate, Sodium Stearoyl Glutamate, Xanthan Gum.

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.
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early skin aging caused by the sun.

Purpose

Information about the drug product’s indications for use.
Uses Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early skin aging caused by the sun.

Spl product data elements

Usually a list of ingredients in a drug product.
Sea and C Sheer Face Serum Avobenzone, Homosalate, Octisalate, Octocrylene OCTISALATE OCTISALATE WATER CALCIUM ALUMINUM BOROSILICATE GLYCERIN CELLULOSE, MICROCRYSTALLINE SODIUM STEAROYL GLUTAMATE HOMOSALATE HOMOSALATE CETOSTEARYL ALCOHOL CARBOXYMETHYLCELLULOSE SODIUM FRUCTOSE GLYCERYL STEARATE SE LAUROYL LYSINE SODIUM GLUCONATE XANTHAN GUM OCTOCRYLENE OCTOCRYLENE BUTYLOCTYL SALICYLATE COCONUT ALKANES TOCOPHEROL ASCOPHYLLUM NODOSUM FUCUS VESICULOSUS WITHANIA SOMNIFERA ROOT ALOE VERA LEAF CAPRYLHYDROXAMIC ACID COCO GLUCOSIDE ETHYL FERULATE COCO-CAPRYLATE/CAPRATE CAFFEINE CAPRYLYL GLYCOL AVOBENZONE AVOBENZONE PROPANEDIOL CALCIUM ASCORBATE

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.
Sea and C Sheer Face Serum SPF 55 Label Sea and C Sheer Face Serum SPF 55 Label

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.
Kep out of reach of children.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? Call toll free 1-888-322-2466 Pacifica Beauty LLC Portland, Oregon

Storage and handling

Information about safe storage and handling of the drug product.
Other information Protect this product from excessive heat & 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. Stop use & ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. 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