NDC 70897-008 Sunscreen Cream Spf 30

Homosalate, Octyl Methoxycinnamate, Benzophenone-3, Titanium Dioxide

NDC Product Code 70897-008

NDC Code: 70897-008

Proprietary Name: Sunscreen Cream Spf 30 Additional informationCallout TooltipWhat 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: Homosalate, Octyl Methoxycinnamate, Benzophenone-3, Titanium Dioxide Additional informationCallout TooltipWhat 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.


Code Structure
  • 70897 - Davemed Healthcare Co., Ltd
    • 70897-008 - Sunscreen Cream Spf 30

NDC 70897-008-01

Package Description: 6 mL in 1 BOTTLE

NDC Product Information

Sunscreen Cream Spf 30 with NDC 70897-008 is a a human over the counter drug product labeled by Davemed Healthcare Co., Ltd. The generic name of Sunscreen Cream Spf 30 is homosalate, octyl methoxycinnamate, benzophenone-3, titanium dioxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Davemed Healthcare Co., Ltd

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 Additional informationCallout TooltipWhat 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.


Sunscreen Cream Spf 30 Active Ingredient(s)

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

  • HOMOSALATE 4 g/100mL
  • TITANIUM DIOXIDE 4 g/100mL
  • OXYBENZONE 3 g/100mL
  • OCTINOXATE 7 g/100mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • VINYL CHLORIDE (UNII: WD06X94M2D)
  • GLATIRAMER ACETATE (UNII: 5M691HL4BO)
  • DIGLYCERIN MONOSTEARATE (UNII: E3XK1VOF1Y)
  • WATER (UNII: 059QF0KO0R)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Davemed Healthcare Co., Ltd
Labeler Code: 70897
FDA Application Number: part352 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-01-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Sunscreen Cream Spf 30 Product Label Images

Sunscreen Cream 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 Ingredients

Active ingredients PurposeHomosalate..................................Sunscreen Octyl methoxycinnamate..............SunscreenBenzophenone-3..........................SunscreenTitanium dioxide...........................Sunscreen

Purpose

Active ingredients PurposeHomosalate..................................Sunscreen Octyl methoxycinnamate..............SunscreenBenzophenone-3..........................SunscreenTitanium dioxide...........................Sunscreen

Uses

  • UsesHelps prevent sunburn Higher SPF gives more protectionFor skin highly sensitive to sunburn

Warnings

  • For external use onlyWhen using this productKeep out eyes. Rinse with water to removeStop use and ask a doctor if rash or irritation develops and lasts

Keep Out Of Reach Of Children

  • Keep out of reach of childrenif swallowed, contact a poison control center or doctor right away

Directions

  • Apply liberally before sun exposure and as neededChildren under 6 months of age: ask a doctor

Inactive Ingredients

Water, Cetearyl Alcohol, Glycerin monosteareate Gctt, Propylparaben, Methylparaben, glycerol, EDTA-2NA, Vinylchloride-methylacrylate, copolymer, Methylisothiazolinone

Other Information

Other InformationStore at room temperature

* Please review the disclaimer below.

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