SUNSCREEN — v4

SUNSCREEN

7 Views

Version

v4

Effective date

September 24, 2025

Original packager

Yes

Sections captured

15

Identifiers

Document ID
3f9113b3-ce3b-5ae8-e063-6294a90accc7
Set ID
0d3687f5-473f-4d4d-af5e-24832ff520e6
Application numbers
M020
Product NDCs
79481-0025
Package NDCs
79481-0025-3
Original packager NDCs
—

Names & Manufacturers

Brand names
SUNSCREEN
Generic names
AVOBENZONE, HOMOSALATE, OCTISALAT, OCTOCRYLENE
Manufacturer names
Meijer Distribution, Inc
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
—
UNII
4X49Y0596W, 5A68WGF6WM, G63QQF2NOX, V06SV4M95S
UPC
—

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10% Purpose sunscreen
Adverse Reactions (1)

Sequence 1

ADVERSE REACTION OUR QUALITY GUARANTEE The Meijer Family www.meijer.com/satisfaction Questions 1-888-593-0593 DIST. BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544 www.meijer.com PLASTIC TUBE how2recycle.info
Do Not Use (1)

Sequence 1

Do not use on damaged or broken skin
Dosage And Administration (1)

Sequence 1

Directions apply liberally 15 minutes before sun exposure apply to all skin exposed to the sun reapply: after 80 minute of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures. Spending time in the sun increases your rist of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with 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 childre under 6 months of age: ask a doctor
Inactive Ingredient (1)

Sequence 1

Inactive ingredients water, diethylhexyl 2,6-naphthalate, styrene/acrylates copolymer, silica, glyceryl stearate, PEG-100 stearate, beeswax, cyclopentasiloxane, acrylates/dimethicone copolymer, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, chlorphenesin, benzyl alcohol, triethanolamine, disodium EDTA, BHT
Indications And Usage (1)

Sequence 1

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
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

principal display panel meijer ® Compare to Neutrogena ® Ultra Sheer ® Sunscreen Broad Spectrum SPF 100+* sheer touch SUNSCREEN LOTION Broad Spectrum SPF 100 WATER RESISTANT (80 MINUTES) Clean, lightweight feel Dermatologist tested Quickly absorbs Non-greasy Oxybenzone & Octinoxate free 3 FL OZ (88 mL) image description
Purpose (1)

Sequence 1

Purpose sunscreen
Spl Product Data Elements (1)

Sequence 1

SUNSCREEN Avobenzone, Homosalate, Octisalat, Octocrylene DIETHYLHEXYL 2,6-NAPHTHALATE STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) SILICON DIOXIDE GLYCERYL MONOSTEARATE PEG-100 STEARATE YELLOW WAX CYCLOMETHICONE 5 CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) CHLORPHENESIN BENZYL ALCOHOL TROLAMINE EDETATE DISODIUM ANHYDROUS BUTYLATED HYDROXYTOLUENE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE WATER
Spl Unclassified Section (1)

Sequence 1

Disclaimers May stain or damage some fabrics or surfaces *This product is not manufactured or distributed by Johnson & Johnson Consumer, Inc., distributor of Neutrogena ® Ultra Sheer ® Dry-Touch Sunscreen Broad Spectrum SPF 100+.
Stop Use (1)

Sequence 1

Stop use and ask a doctor if rash occurs
Storage And Handling (1)

Sequence 1

Other information protect the product in this container from excessive heat and dirtect sun
Warnings (1)

Sequence 1

Warnings For external use only When using this product keep out of eyes. Rinse with water to remove. Do not use on damaged or broken skin 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.
When Using (1)

Sequence 1

When using this product keep out of eyes. Rinse with water to remove.

OpenFDA raw payload

{'application_number': ['M020'],
 'brand_name': ['SUNSCREEN'],
 'generic_name': ['AVOBENZONE, HOMOSALATE, OCTISALAT, OCTOCRYLENE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Meijer Distribution, Inc'],
 'package_ndc': ['79481-0025-3'],
 'product_ndc': ['79481-0025'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['3f9113b3-ce3b-5ae8-e063-6294a90accc7'],
 'spl_set_id': ['0d3687f5-473f-4d4d-af5e-24832ff520e6'],
 'substance_name': ['AVOBENZONE', 'HOMOSALATE', 'OCTISALATE', 'OCTOCRYLENE'],
 'unii': ['G63QQF2NOX', 'V06SV4M95S', '4X49Y0596W', '5A68WGF6WM']}