MEIJER SPF 4 DARK TANNING OIL- avobenzone, octocrylene oil

Meijer by

Drug Labeling and Warnings

Meijer by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 1%

Octocrylene 1%

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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

Directions

• shake well before use
• apply liberally 15 minutes before sun exposure and rub into skin
• hold container 4 to 6 inches from the skin to apply
• do not spray directly into face. Spray on hands then apply to face
• reapply:
• after 80 minutes of swimming or sweating
• inmediately after towel drying
• at least every 2 hours
• children under 6 months: Ask a doctor

Inactive Ingredients

Acetylated Lanolin Alcohol, Aleurites Moluccana Seed Oil, Aloe Barbadensis Leaf Extract, BHT, Caprylic/Capric Triglyceride, Cetyl Acetate, Cocos Nucifera (Coconut) Oil, Diethylhexyl Syringylidene-Malonate, Fragrance, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Lanolate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mineral Oil, Olea Europaea (Olive) Fruit Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, VP/Hexadecene Copolymer

Other Information

• Protect this product from excessive heat and direct sun
• May stain some fabrics or surfaces

Meijer 4 Dark Tanning Oil Spray Sunscreen

INGREDIENTS AND APPEARANCE

MEIJER  SPF 4 DARK TANNING OIL
avobenzone, octocrylene oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0266
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9.03 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	9.03 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TEA TREE OIL (UNII: VIF565UC2G)
MINERAL OIL (UNII: T5L8T28FGP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
COCOA BUTTER (UNII: 512OYT1CRR)
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)
KUKUI NUT OIL (UNII: TP11QR7B8R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
OLIVE OIL (UNII: 6UYK2W1W1E)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL ACETATE (UNII: 4Q43814HXS)
COCONUT OIL (UNII: Q9L0O73W7L)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
SOYBEAN OIL (UNII: 241ATL177A)
LANOLIN ACID (UNII: D1CZ545P7Z)
SUNFLOWER OIL (UNII: 3W1JG795YI)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0266-4	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/04/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/04/2019

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	manufacture(58443-0266) , pack(58443-0266) , label(58443-0266) , analysis(58443-0266)