MEIJER SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene liquid

Meijer SPF 50 Sunscreen by

Drug Labeling and Warnings

Meijer SPF 50 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Meijer, Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

PURPOSE

Sunscreen

INDICATIONS & USAGE

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.

Flammable. Do not use while smoking or near heat or flame.

Do not use on damaged or broken skin.

When using this product avoid contact with eyes. Rinse eyes with water to remove, contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.

Stop use and ask a doctor if rash or irritation develops and lasts.

KEEP OUT OF REACH OF CHILDREN

If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure. 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, hold container 4 to 6 inches from the skin to apply, do not spray directly onto face Spray onto hand then apply to face, do not apply in windy conditions, use in well-ventilated area.

INACTIVE INGREDIENT

Alcohol denat., acrylates/octylacrylamide copolymer, tocopherol, glycerin, caprylic/capric triglyceride, diethylhexyl syringylidenemalonate, fragrance.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEIJER SPF 50 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79481-1389
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALCOHOL (UNII: 3K9958V90M)
TOCOPHEROL (UNII: R0ZB2556P8)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
ACRYLATES/OCTYLACRYLAMIDE COPOLYMER (40000 MW) (UNII: 7LL6SY9YFV)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79481-1389-6	170 g in 1 CAN; Type 0: Not a Combination Product	04/01/2024
2	NDC: 79481-1389-7	170 g in 1 CAN; Type 0: Not a Combination Product	04/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/28/2024

Labeler - Meijer (006959555)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(79481-1389)