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NDC 41250-0796-83 Meijer Zinc SPF 50 4; 5 g/100g; g/100g Details

Meijer Zinc SPF 50 4; 5 g/100g; g/100g

Meijer Zinc SPF 50 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Meijer Distribution, Inc.. The primary component is OCTOCRYLENE; ZINC OXIDE.

Product Information

NDC	41250-0796
Product ID	41250-796_682512d7-1458-48d9-813e-cd07f74e23e1
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Meijer Zinc SPF 50
Proprietary Name Suffix	n/a
Non-Proprietary Name	Octocrylene, Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	4; 5
Active Ingredient Units	g/100g; g/100g
Substance Name	OCTOCRYLENE; ZINC OXIDE
Labeler Name	Meijer Distribution, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 41250-0796-83 (41250079683)

Pricing Information	N/A
NDC Package Code	41250-796-83
Billing NDC	41250079683
Package	118 g in 1 TUBE (41250-796-83)
Marketing Start Date	2016-04-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9983f672-da35-4b1b-802c-aa4c1490d720 Details

Active Ingredients

Octocrylene 4.0%, Zinc Oxide 5.0%

Purpose

Sunscreen

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

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.

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.

• May stain some fabrics

Directions

• 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 of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m. to 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

• children under 6 months of age: Ask a doctor

Inactive ingredients

Water, Ethylhexyl Stearate, Diisopropyl Adipate, Cetyl Dimethicone, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Beeswax, Isohexadecane, Sodium Chloride, Hydrogenated Castor Oil, Silica, Triethoxycaprylylsilane, Dimethicone, Tocopherol, Disodium EDTA, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate, henoxyethanol, Methylparaben, Propylparaben.

Other information

protect this product from excessive heat and direct sun

Questions or comments?

Call 1-800-697-9868 Mon-Fri

Principal Display Panel

NDC: 41250-796-83

meijer

Vanishing Zinc

Sunscreen

Lotion

Dermatologist tested

UVA/UVB protection

Broad Spectrum

SPF 50

Water Resistant

(80 minutes)

Non-greasy

Goes on clear

4 FL. OZ. (118 mL)

INGREDIENTS AND APPEARANCE

MEIJER ZINC SPF 50

octocrylene, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-796
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
YELLOW WAX (UNII: 2ZA36H0S2V)
ISOHEXADECANE (UNII: 918X1OUF1E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41250-796-83	118 g in 1 TUBE; Type 0: Not a Combination Product	04/06/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/10/2016

Labeler - Meijer Distribution, Inc. (006959555)

Revised: 3/2016

Document Id: 682512d7-1458-48d9-813e-cd07f74e23e1

Set id: 9983f672-da35-4b1b-802c-aa4c1490d720

Version: 1

Effective Time: 20160310