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NDC 41250-0707-22 Meijer Sheer SPF 30 3; 8; 5; 4; 4 g/100g; g/100g; g/100g; g/100g; g/100g Details

Meijer Sheer SPF 30 3; 8; 5; 4; 4 g/100g; g/100g; g/100g; g/100g; g/100g

Meijer Sheer SPF 30 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Meijer Distribution, Inc.. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE.

Product Information

NDC	41250-0707
Product ID	41250-707_c2ec20e7-0b89-408e-b78f-459c0c80ac02
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 Sheer SPF 30
Proprietary Name Suffix	n/a
Non-Proprietary Name	Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	3; 8; 5; 4; 4
Active Ingredient Units	g/100g; g/100g; g/100g; g/100g; g/100g
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
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 41250-0707-22 (41250070722)

Pricing Information	N/A
NDC Package Code	41250-707-22
Billing NDC	41250070722
Package	88 g in 1 BOTTLE (41250-707-22)
Marketing Start Date	2016-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7da626f5-1ad7-4ea9-802d-302cf232ebf9 Details

Active ingredients

Avobenzone 3.0%, Homosalate 8.0%, Octisalate 5.0%, Octocrylene 4.0%, Oxybenzone 4.0%

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: Ask a doctor

Inactive Ingredients

Water, Caprylyl Methicone, Glyceryl Stearate, PEG-100 Stearate, Cetyl Alcohol, Propylene Glycol, Silica, Benzyl Alcohol, Caprylyl Glycol, Diethylhexyl 2,6-Naphthalate, Phenoxyethanol, Sodium Polyacrylate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Chlorphenesin, Cetyl Dimethicone, Dimethicone, Xanthan Gum, Fragrance, Behenyl Alcohol, Ethylhexyl Stearate, Trideceth-6, Disodium EDTA, Ethylhexylglycerin, BHT.

Other information

protect this product from excessive heat and direct sun

Questions or comments?

Call 1-800-697-9868 Mon-Fri

Principle Display Panel

NDC: 41250-707-22

meijer

Sheer

Sunscreen

lotion

light, clean feel

dermatologist tested

Broad Spectrum

SPF 30

Water Resistant

(80 minutes)

3 FL. OZ. (88 mL)

INGREDIENTS AND APPEARANCE

MEIJER SHEER SPF 30

avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-707
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 g in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
XANTHAN GUM (UNII: TTV12P4NEE)
DOCOSANOL (UNII: 9G1OE216XY)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41250-707-22	88 g in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	06/01/2016

Labeler - Meijer Distribution, Inc. (006959555)

Revised: 5/2016

Document Id: c2ec20e7-0b89-408e-b78f-459c0c80ac02

Set id: 7da626f5-1ad7-4ea9-802d-302cf232ebf9

Version: 1

Effective Time: 20160531