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NDC 41250-0705-57 Meijer Baby Tear Free SPF 50 3.2; 4 g/100g; g/100g Details

Meijer Baby Tear Free SPF 50 3.2; 4 g/100g; g/100g

Meijer Baby Tear Free SPF 50 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Meijer Distributing Inc.. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	41250-0705
Product ID	41250-705_33740434-87f8-4b89-b984-4610c428f359
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 Baby Tear Free SPF 50
Proprietary Name Suffix	n/a
Non-Proprietary Name	Titanium Dioxide, Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	3.2; 4
Active Ingredient Units	g/100g; g/100g
Substance Name	TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	Meijer Distributing 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 41250-0705-57 (41250070557)

Pricing Information	N/A
NDC Package Code	41250-705-57
Billing NDC	41250070557
Package	295 g in 1 BOTTLE (41250-705-57)
Marketing Start Date	2016-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2434de23-bcc9-4a83-9945-16fc3f2b8c61 Details

Active Ingredients

Titanium Dioxide 3.2%, Zinc Oxide 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, Caprylic/Capric Triglyceride, Isohexadecane, Butyloctyl Salicylate, Octyldodecyl Citrate Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Sodium Chloride, Ethylhexyl Methoxycrylene, Dimethicone, Phenoxyethanol, Caprylyl Glycol, PEG-8, Alumina, Glycerin, Sodium Citrate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

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: 4150-705-57

meijer

tear free

baby

Sunscreen

lotion

pediatrician tested

UVA/UVB protection

Broad Spectrum

SPF 50

Water Resistant

(80 minutes)

10 FL. OZ. (295 mL)

INGREDIENTS AND APPEARANCE

MEIJER BABY TEAR FREE SPF 50

titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-705
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.2 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOHEXADECANE (UNII: 918X1OUF1E)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
ALUMINUM OXIDE (UNII: LMI26O6933)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41250-705-57	295 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 Distributing Inc. (006959555)

Revised: 6/2016

Document Id: 33740434-87f8-4b89-b984-4610c428f359

Set id: 2434de23-bcc9-4a83-9945-16fc3f2b8c61

Version: 1

Effective Time: 20160601