Drug labels

Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45

AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE · Kenvue Brands LLC · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
51f3d6ca-3189-4380-9afb-4259ba878274
ID
5b1cfad8-ac9a-b950-e063-6294a90a7433
Effective time
20260910
Version
12
SPL product data elements

Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45 avobenzone, homosalate, octisalate, and octocrylene AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE ALCOHOL ISOBUTANE DICAPRYLYL CARBONATE POLYESTER-7 ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) NEOPENTYL GLYCOL DIHEPTANOATE .ALPHA.-TOCOPHEROL ACETATE

SPL unclassified section
Drug Facts, Distributed by: Kenvue Brands LLC Summit, NJ 07901
Active ingredient
Active ingredients Purpose Avobenzone 3% Sunscreen Homosalate 10% Sunscreen Octisalate 5% Sunscreen Octocrylene 10% Sunscreen
Active ingredient table

<table width="50%"><col width="75%" align="left" valign="top"/><col width="25%" align="left" valign="top"/><thead><tr><th><content styleCode="italics">Active ingredients</content></th><th><content styleCode="italics">Purpose</content></th></tr></thead><tbody><tr><td>Avobenzone 3%</td><td>Sunscreen</td></tr><tr><td>Homosalate 10%</td><td>Sunscreen</td></tr><tr><td>Octisalate 5%</td><td>Sunscreen</td></tr><tr><td>Octocrylene 10%</td><td>Sunscreen</td></tr></tbody></table>

Purpose
Active ingredients Purpose Avobenzone 3% Sunscreen Homosalate 10% Sunscreen Octisalate 5% Sunscreen Octocrylene 10% Sunscreen
Purpose table

<table width="50%"><col width="75%" align="left" valign="top"/><col width="25%" align="left" valign="top"/><thead><tr><th><content styleCode="italics">Active ingredients</content></th><th><content styleCode="italics">Purpose</content></th></tr></thead><tbody><tr><td>Avobenzone 3%</td><td>Sunscreen</td></tr><tr><td>Homosalate 10%</td><td>Sunscreen</td></tr><tr><td>Octisalate 5%</td><td>Sunscreen</td></tr><tr><td>Octocrylene 10%</td><td>Sunscreen</td></tr></tbody></table>

Indications and usage

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

Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. keep away from face to avoid breathing it 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 Warning: Flammable. Contents under pressure. Do not use near fire, heat or while smoking. Do not puncture or incinerate. Store at temperature below 120°F (48°C). Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Do not use
Do not use on damaged or broken skin
When using
When using this product keep out of eyes. Rinse with water to remove. keep away from face to avoid breathing it
Stop use
Stop use and ask a doctor if rash occurs
Keep out of reach of children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Dosage and administration

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 long-sleeved shirts, pants, hats, and sunglasses children under 6 months of age: Ask a doctor

Storage and handling
Other information protect this product from excessive heat and direct sun may stain some fabrics
Inactive ingredient

Inactive ingredients Alcohol Denat., Isobutane, Dicaprylyl Carbonate, Polyester-7, Acrylates/Octylacrylamide Copolymer, Neopentyl Glycol Diheptanoate, Fragrance, Tocopheryl Acetate

Questions
Questions or Comments? Call toll-free 800-299-4786 or 215-273-8755 (collect). www.neutrogena.com
Package label principal display panel

PRINCIPAL DISPLAY PANEL - 141 g Can Label NEW LOOK Neutrogena ® DERMATOLOGIST RECOMMENDED BRAND ULTRA SHEER ® Body Mist Sunscreen 45 BROAD SPECTRUM SPF 45 Antioxidant Vitamin E Lightweight clean feel Shields skin 6 layers deep with HELIOPLEX ® Water resistant (80 minutes) NET WT 5.0 OZ (141 g) Neutrogena_1

Harmonized identifiers (openFDA)
Application number
M020
Brand name
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45
Generic name
AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE
Manufacturer name
Kenvue Brands LLC
Product NDC
69968-0579
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
SPL ID
5b1cfad8-ac9a-b950-e063-6294a90a7433
SPL set ID
51f3d6ca-3189-4380-9afb-4259ba878274
Package NDC
69968-0579-8, 69968-0579-5
Is original packager
true
Upc
0086800100393
UNII
G63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.