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NDC 00363-0962-09 WALGREENS KIDS BABY SPF 50 31; 40 mg/mL; mg/mL Details

WALGREENS KIDS BABY SPF 50 31; 40 mg/mL; mg/mL

WALGREENS KIDS BABY SPF 50 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by WALGREEN COMPANY. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	00363-0962
Product ID	0363-0962_c50cf225-c894-b0af-e053-2995a90a62e3
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	WALGREENS KIDS BABY 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	31; 40
Active Ingredient Units	mg/mL; mg/mL
Substance Name	TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	WALGREEN COMPANY
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00363-0962-09 (00363096209)

Pricing Information	N/A
NDC Package Code	0363-0962-09
Billing NDC	00363096209
Package	88 mL in 1 TUBE (0363-0962-09)
Marketing Start Date	2021-05-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c50bdf7e-a80b-794a-e053-2995a90ad881 Details

Active Ingredients

Titanium Dioxide 3.1%

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

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

• children under 6 months of age: ask a doctor

• 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. - 2 p.m.

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

Other information

• protect this product from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

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, caprylyl glycol, PEG-8, silica, triethoxycaprylylsilane, glycerin, sodium citrate, tocopheryl acetate, aloe barbadensis leaf juice, propanediol, pentylene glycol, phenethyl alcohol

Label

WALG BABY SPF 50 LOTION

3 fl oz (88 mL)

NDC 0363-0962-09

INGREDIENTS AND APPEARANCE

WALGREENS KIDS BABY SPF 50

titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0962
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	31 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	40 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOHEXADECANE (UNII: 918X1OUF1E)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PROPANEDIOL (UNII: 5965N8W85T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0962-09	88 mL in 1 TUBE; Type 0: Not a Combination Product	05/21/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/21/2021

Labeler - WALGREEN COMPANY (008965063)

Revised: 6/2021

Document Id: c50cf225-c894-b0af-e053-2995a90a62e3

Set id: c50bdf7e-a80b-794a-e053-2995a90ad881

Version: 2

Effective Time: 20210618