NDC 81574-002 Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum Spf 30

Titanium Dioxide , Zinc Oxide

NDC Product Code 81574-002

NDC CODE: 81574-002

Proprietary Name: Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum Spf 30 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Titanium Dioxide , Zinc Oxide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 81574 - Skinlycious Pte Ltd

NDC 81574-002-01

Package Description: 30 mL in 1 BOTTLE, PUMP

NDC 81574-002-02

Package Description: 5 mL in 1 BOTTLE, PUMP

NDC Product Information

Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum Spf 30 with NDC 81574-002 is a a human over the counter drug product labeled by Skinlycious Pte Ltd. The generic name of Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum Spf 30 is titanium dioxide , zinc oxide. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 251577.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum Spf 30 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Skinlycious Pte Ltd
Labeler Code: 81574
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-01-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum Spf 30 Product Label Images

Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum Spf 30 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Salicylic Acid 2%

Purpose

Acne treatment

Sunscreen

Uses

• For the treatment of acne


• Helps prevent development of new acne blemishes

• helps prevent sunburn


• provides high protection against 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

Warnings

For External Use OnlyDo not use if• are pregnant


• are a child under 3 years of age


• are allergic to salicylates


When using this product• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.


• Avoid unnecessary sun exposure and use a sunscreen.


• Avoid contact with the eyes, lips and mouth.


• First time users may experience tingling sensation and visible peeling. After frequent usage, tingling and peeling will likely reduce.


Stop use and ask a doctor if


• Irritation becomes severe

For External Use OnlyDo 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Direction

• Cleanse the skin thoroughly before applying this product


• For treatment of acne, wet cotton bud or pad with solution and cover the entire affected area with a thin layer one to three times daily. Suitable for both facial and body acne.


• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.


• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.


• Complement this with other Skinlycious products to reduce the likelihood of skin dryness.


• For full face exfoliant, wet cotton pad with a solution and apply a thin layer in the evening only over the entire face. No need to rinse off. Once skin condition improves, reduce frequency to no more than 3-5 times a week in the evening only.

Inactive Ingredients

Water, Alcohol Denat. Mandelic Acid, Glycerin, Purslane, Butylene Glycol, Phenoxyethanol, Ethylhexylglycerin.

Water, Cyclopentasiloxane, PEG-10 Dimethicone, Hydrogenated Polydecene, Butylene Glycol, HDI/Trimethylol Hexyllactone Crosspolymer, Hydrogen Dimethicone, Ethylene/Acrylic Acid Copolymer, Silica, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Disteardimonium Hectorite, Olea Europaea Leaf Extract, Phenoxyethanol, Sodium Chloride, Aluminium Hydroxide, Allantoin, Sodium Citrate, Ethylhexylglycerin.

Other Information

• Store in a cool dry place away from direct sun.

• protect this product from excessive heat and direct sun

Active Ingredients

Titanium Dioxide 3.3%Zinc Oxide 13.8%

Directions

• Apply liberally 15 minutes before sun exposure.


• Apply to all skin exposed to the sun.


• Reapply at least every 2 hours.


• Use a water resistant sunscreen if swimming or sweating.


• Children under 6 months: 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 10a.m.-2p.m.


- wear long-sleeved shirts, pants, hats and sunglasses.

* Please review the disclaimer below.