NDC 58133-652 Spf30

Zinc Oxide

NDC Product Code 58133-652

NDC 58133-652-33

Package Description: 100 mL in 1 TUBE

NDC 58133-652-35

Package Description: 100 mL in 1 TUBE

NDC 58133-652-36

Package Description: 100 mL in 1 TUBE

NDC Product Information

Spf30 with NDC 58133-652 is a a human over the counter drug product labeled by Cosmetic Specialty Labs, Inc.. The generic name of Spf30 is zinc oxide. The product's dosage form is lotion and is administered via topical form.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Spf30 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.


Inactive Ingredient(s)

About 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.

  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • SAFFLOWER OIL (UNII: 65UEH262IS)
  • GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • CHAMOMILE (UNII: FGL3685T2X)
  • MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • COMFREY (UNII: D05HXK6R3G)

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.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • 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: Cosmetic Specialty Labs, Inc.
Labeler Code: 58133
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: 07-30-2021 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.

Spf30 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

Zinc Oxide

Purpose

Sunscreen

Sun Alert:

Limiting sun exposure, wearing protective clothing, and using broad spectrum sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Uses

Helps prevent sunburn. Used as directed with other sun proctection measures, decreases skin cancer risk and early skin aging, caused by the sun.

Caution

Keep out of direct sunlight and excessive heat. Some natural seperation may occur. Shake well before using.

Warnings

For external use only. Do not ingest. Keep out of eyes; rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact poison control.

Other Information

Protect this product from excessive heat or direct sun.

Directions: Fda Recommends

  • Applying 15 minutes before sun exposureUsing a water resistant sunscreen if swimming or sweatingReapplying at least every 2 hoursFor children under 6 months: consult pediatrician

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Beeswax, Butyrospermum parkii (Shea) Butter, C12-15 Alkyl Benzoate, Candelilla (Euphorbia Cerifera) Wax, Carthamus tinctorius (Safflower) Seed Oil, Chamomilla recutita (Matricaria) Flower Extract, Cocos nucifera (Coconut) Oil, Glyceryl Caprylate, Glyceryl Undecylenate, Helianthus annuus (Sunflower) Seed Oil, Lavandula angustifolia (Lavender) Oil, Mangifera indica (Mango) Seed Butter, Olea europaea (Olive) Fruit Oil, Persea gratissima (Avocado) Oil, Symphytum officinale (Comfrey) Leat Extract, Theobroma cacao (Cocoa) Seed Butter, Tocopherol, Triethoxycaprylylsiloxane

* Please review the disclaimer below.