NDC 73310-5033 Sun Spr Spf 50

Avobenzone, Octinoxate, Octocrylene, Oxybenzone, Titanium Dioxide

NDC Product Code 73310-5033

NDC 73310-5033-3

Package Description: 150 mL in 1 BOTTLE, SPRAY

NDC Product Information

Sun Spr Spf 50 with NDC 73310-5033 is a a human over the counter drug product labeled by Agefarm Srl. The generic name of Sun Spr Spf 50 is avobenzone, octinoxate, octocrylene, oxybenzone, titanium dioxide. The product's dosage form is spray and is administered via topical form.

Labeler Name: Agefarm Srl

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Sun Spr Spf 50 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.

  • OCTINOXATE 1 mg/5mL
  • OCTOCRYLENE 1 mg/5mL
  • OXYBENZONE 1 mg/5mL
  • AVOBENZONE 1 mg/5mL

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.


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.

Product Labeler Information

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

Labeler Name: Agefarm Srl
Labeler Code: 73310
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 08-28-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Sun Spr Spf 50 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





Helps prevent sunburnuse as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun


For external use onlyDo not use on damaged or broken skin
Stop use and ask 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 Poison Control Center right away.


SUNSCREEN 5033 BODY SPRAY SPF 50.jpgapply liberally 15 minutes before the sun exposure
reapplyat least every 2 hours, immediately after towel dryinguse a water-resistant sunscreen if swimming or sweatingchildren 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 a broad spectrum SPF value of 15 or higher and other sun protection measures including
limit the time in the sun, especially from 10 a.m. - 2p.m.wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

Alcohol, BHT, bis-ethylhexyloxyphenol methoxphenyl triazine, butyrospermum parkii butter extract, caprylic - capric triglyceride, carthamus tinctorius seed oil, cellulose gum, citronellol, coumarin, cyclomethicone, c12-15 alkyl benzoate, decyl glucose, diisopropyl sebacate, dimethicone, glycerin, hexyl cinnamal, coumarin, hydrolyzed soy protein, hydrolyzed whaet protein, lecithin, limnanthes alba seed oil, limonene, linalool, methylene bis-benzotriazoly tetramethybutyphenol (nano), methylisothizolinone, menthyl lactate, microcrystalline cellulose, olea europapea oil unsonifiables, parfum, phenoxyhetanol, potassium cetyl phosphate, propylene gycol, silica, tocopheryl acetate, tripeptide-1, vp-eicosene copolymer, water, xanthan gum

Storage And Handling

Protect this product from excessive heat and direct sun

Principal Label


* Please review the disclaimer below.