MEIJER SPF 4 DARK TANNING OIL- avobenzone, octocrylene oil
Prime Enterprises Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Meijer 4 Dark Tanning Oil Spray Sunscreen

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

Principal Display Label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)
KUKUI NUT OIL (UNII: TP11QR7B8R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SOYBEAN OIL (UNII: 241ATL177A)
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)
LANOLIN ACID (UNII: D1CZ545P7Z)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
TEA TREE OIL (UNII: VIF565UC2G)
MINERAL OIL (UNII: T5L8T28FGP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SUNFLOWER OIL (UNII: 3W1JG795YI)
COCOA BUTTER (UNII: 512OYT1CRR)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0266-4	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/04/2019	03/14/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	02/04/2019	03/14/2019

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

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

Revised: 5/2022

Document Id: ded2fd55-99e7-088c-e053-2995a90ac367

Set id: 7ea8faae-37a8-4aa4-e053-2a91aa0aa83b

Version: 3

Effective Time: 20220512

Prime Enterprises Inc.