Sport Ultra

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPICAL HUMAN OTC DRUG

Sport Ultra is an FDA drug label for the active ingredient AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE manufactured by Guangzhou Danting Bath&Body Care Industry Co. Ltd administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260522.

Generic name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Manufacturer
Guangzhou Danting Bath&Body Care Industry Co. Ltd
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
75376-697
Application
M020
Label effective
20260522

About this product

Sport Ultra is an FDA-registered drug product whose active ingredient is AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE. It is labelled by Guangzhou Danting Bath&Body Care Industry Co. Ltd taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 75376-697, application M020, label effective 20260522. It is one of 105 FDA drug label records sharing the active ingredient AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE are most often described in connection with: helps prevent, sun protectiion, measures see, directions decreases, risk skin, aging caused. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active Ingredients Avobenzone 2.7%, Homosalate 9%, Octisalate 4.5%, Octocrylene 6.5%

Indications & Usage

Uses • helps prevent sunburn • If used as directed with other sun protectiion measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage & Administration

Directions • Apply liberally 15 minutes before sun exposure • reapply: • after 80 minues of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 a broad spectrum SPF of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10:00 a.m.-2:00 p.m. • wear long-sleeve shirts, pants, hats, and sunglasses • children under 6 months of age: Ask a doctor.

Warnings

Warnings For external use only. Flammable: • keep away from fire or flame • wait 10 minutes after application before approaching a source of heat or flame, or before smoking Do not use • on damaged or broken skin. When using this product • Keep out of eyes. Rinse with water to remove Stop use and ask a doctor if • rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away 1-800-222-1222.

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How products containing AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE compare

FDA lists 105 drug label records with AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Sun Life Brands, LLC 9
— — TARGET CORPORATION 9
— — Meijer Distribution, Inc. 4
— — COOLA LLC 3
— — Derma Care Research Labs, LLC 3

Recall and safety notices

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-1365-2022 BANANA BOAT SPRT CLR SPRY SPF50 6 FL OZ SKU 2007524 SUNTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2096102 HAWAIIAN TROPIC TANNING OIL SPRAY PUMP SPF 25 8 FL OZ SKU 2096111 BANANA BOAT SPORT ULTRAMIST SPRAY SPF 65 6 OZ SKU 2096117 COPPERTONE WATERBABIES LOTION SPF 50 8 FL OZ SKU 2097635 COPPERTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2097636 BANANA BOAT SPRT LTION SPF 50 8 FL OZ SKU 2099592 HAWAIIAN TROPIC SHEER TOUCH LOTION SPF 30 8 FL OZ SKU 2006432 BB KIDS SUN SCREEN MIST SPRAY SPF 100 6 OZ SKU 2007523 SUNTONE KIDS SPRAY SPF 50 6 OZ SKU 2096096 NEUTROGENA BCH DFNSE SPR SPF 70 SKU 2097632 BANANA BOAT KDS SPRT SPRY SPF50 6FL OZ SKU 2097655 BANANA BOAT DRY OIL MST SPRY 15 SPF 6 OZ SKU 2097794 BANANA BOAT TAN DRY OIL MIST 4 SPF 6 OZ SKU 2097144 COPPERTONE GLOW SPRAY SPF 50 5OZ SKU 2096124 COPPERTONE SPORT LOTION SPF 50 8.75 FLOZ SKU 2096130 NEUTROGENA ULTRA SHEER LOTN SPF 55 3 FL OZ SKU 2097637 SUNTONE KIDS LOTION SPF 50 6 FL OZ SKU 2096101 BANANA BOAT SPORT ULTRA MIST 30 SPF 6 OZ SKU 2097141 COPPERTONE SPORT SPRAY SPF30 5.5OZ SKU 2097083 SUNTONE SPORT SPRAY SPF 70 5.5 OZ SKU 2008234 SUNTONE SPORT LOTION SPF 50 6 FL OZ SKU 2096099 COPPERTONE KIDS SPRAY SPF 50 5.5 OZ SKU 2097084 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831

Frequently asked questions

What is Sport Ultra used for?
Uses • helps prevent sunburn • If used as directed with other sun protectiion measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Who makes Sport Ultra?
Guangzhou Danting Bath&Body Care Industry Co. Ltd is the labeler of record for Sport Ultra. 105 FDA label records share the active ingredient AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Sport Ultra come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Sport Ultra prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE?
Yes. 105 FDA drug label records list AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Sport Ultra been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.