NDC 52854-538 Reef Kids Spf 30 Oxybenzone Free

Octocrylene, Octisalate, And Avobenzone Spray Topical

NDC Product Information

Reef Kids Spf 30 Oxybenzone Free with NDC 52854-538 is a human over the counter drug product labeled by Tropical Seas, Inc.. The generic name of Reef Kids Spf 30 Oxybenzone Free is octocrylene, octisalate, and avobenzone. The product's dosage form is spray and is administered via topical form.

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.

Reef Kids Spf 30 Oxybenzone Free 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.

  • ALCOHOL (UNII: 3K9958V90M)

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: Tropical Seas, Inc.
Labeler Code: 52854
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: 12-07-2020 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.

Reef Kids Spf 30 Oxybenzone Free Product Label Images

Reef Kids Spf 30 Oxybenzone Free 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


Drug Facts

Active Ingredients

Octocrylene 5.0%Octisalate 3.0%Avobenzone 2.5%




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


For external use onlyFlammable: Do not use near heat, flame, or while smoking

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

  • When using this product:
  • Keep out of eyes. Rinse with water to remove.Do not puncture or incinerate. Contents under pressure.Do not store at temperatures above 120° F

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.


  • Apply liberally 15 minutes before sun exposuredo not spray directly on face - spray into hands and apply to facehold approximately 4 - 6 inches from skin to sprayrub into skin evenly to ensure appropriate coverageuse in a well-ventilated areaavoid inhaling or exposing others to spraydo not apply in windy conditionsreapply:
  • After 80 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hoursSun 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 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.wear long-sleeve shirts, pants, hats and sunglasseschildren under 6 months: Ask a doctor

Inactive Ingredients

Sd alcohol 40-b, deionized water, lauryl lactate, cyclopentasiloxane, c12-15 alcohols benzoate, acrylates octylacrylamide copolymer, octyldodecyl neopentanoate, octyl dodecyl citrate crosspolymer, phenethyl benzoate, and fragrance.

Other Information

  • Protect this product from excessive cold, heat, and direct sun.store at temp below 90º F and avoid long term storagemay stain fabrics or surfaces

* Please review the disclaimer below.