NDC 70412-316 Spf15

Avobenzone, Homosalate, Octocrylene, Octisalate

NDC Product Code 70412-316

NDC 70412-316-07

Package Description: 2 g in 1 TUBE

NDC 70412-316-15

Package Description: 4.5 g in 1 TUBE

NDC 70412-316-20

Package Description: 5.67 g in 1 TUBE

NDC Product Information

Spf15 with NDC 70412-316 is a a human over the counter drug product labeled by Zhejiang Ayan Biotech Co.,ltd.. The generic name of Spf15 is avobenzone, homosalate, octocrylene, octisalate. The product's dosage form is lipstick and is administered via topical form.

Dosage Form: Lipstick - A waxy solid, usually colored cosmetic, in stick form for the lips.

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.

Spf15 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: Zhejiang Ayan Biotech Co.,ltd.
Labeler Code: 70412
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: 06-01-2018 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: 12-31-2021 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.

Spf15 Product Label Images

Spf15 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 Ingredients

Avobenzone 3%, Homosalate 10%,


Octocrylene10%, Octisalate 5%

Avobenzone 3%,Homostate 10%,Octocrylene 10%,Octisalate 5%

Avobenzone 2%


Octocrylene 8%


Octisalate 5.5%


Homosalate 2%

Purpose

Sunscreen

Sunscreen

Sunscreen

Uses

•Helps prevent sunburn

  • Helps prevent sunburn

  • Helps prevent sunburn.

Warnings:

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer or early skin aging. This product has been shown only to prevent sunburn


NOT skin cancer or early skin aging. This product is


NOT water resistant or sweat resistant.


For external use only.

Do Not Use

On damaged or broken skin.

On damaged or broken skin.

On damaged or broken skin.

When Using This Product

Keep out of eyes. Rinse with water to remove.

Keep out of eyes. Rinse with water to remove.

Keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor

If rash occurs.

If rash occurs.

If reash occurs.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

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 right away.

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


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 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.

  • Non-Water Resistant ProductApply liberally 15 minutes before sun exposureUse a water resistant sunscreen if swimming or sweatingReapply at least every 2 hoursChildren under 6 months: Ask a doctorSun 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 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.

  • 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 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

Other Information

• Protect this product from excessive heat and direct sun

• Protect this product from excessive heat and direct sun

  • Protect from excessive heat and direct sun.

Questions?

Call AP Specialties

Call toll free

Call AP SpecialtiesBATCH NO:Distributed by:

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cnacer or early skin aging. this product has been shown only to prevent sunburn


NOT skin cancer or early skin aging. this product is


NOT water resistant or sweat resistant.


For external use only.

For external use only.

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

Mineral Oil, Ozokerite, Cera Microcristallina, Polyisobutene, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Polyethylene, Tridencyl Trimellitate, Butyrospermum Parkii (Shea Butter), BHT, Tocopheryl Acetate, Fragrance.

* Please review the disclaimer below.