Sun Wave Cross Sport Insta Dry Spf 50 Spray
FDA Label NDC 84665-007

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sun Life Brands, Llc for the product Sun Wave Cross Sport Insta Dry Spf 50 (NDC 84665-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Avobenzone 3%, Homosalate 10%,
Octisalate 5%, Octocrylene 10%

Purpose

Sunscreen

Uses

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

Warnings

  • For external use only

Do Not Use

  • on damaged or broken skin

When Using This Product

• keep away from face to avoid breathing it • 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 swallowed, get medical help or contact a Poison Control Center right away.
  • Caution: Flammable. Contents under pressure.
    Do not use near fire, heat or while smoking. Do not puncture or incinerate. Do not store at temperatures above 120° F (48° C). Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Directions

• spray liberally and spread evenly by hand 15 minutes before sun exposure • hold container 4-6 inches from the skin to apply. Rub in. • do not spray directly into face. Spray on hands and then apply to face. Rub in. • do not apply in windy conditions • use in a well-ventilated area • reapply: • after 80 minutes 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 value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. – 2 p.m. • wear longsleeved shirts, pants, hats and sunglasses • Children under 6 months: Ask a doctor.

Other Information

• protect this product from excessive heat and direct sun • may stain some fabrics, wood, plastics, vinyl • for use on skin only • Store between 20° to 25° C (68° to 77° F)

Inactive Ingredients

Alcohol Denatured, Glycerin, Coconut Oil, Acrylates Octylacrylamide Crosspolymer, Fragrance, Polysorbate 20, Jojoba Extract, Aloe Vera, L-Ascorbic Acid [VitaminC], Retinol [Vitamin A], Cholecalciferol [VitaminD], Tocopherol [Vitamin E].

Questions Or Comments?

Call 321.431.0000
or visit sunwavesuncare.com

Package Labeling:

Label8 (Label8)

Label8 (Label8)

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