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NDC 36800-0257-09 TopCare Everyday Kids Mineral Sunscreen 216 mg/mL Details

TopCare Everyday Kids Mineral Sunscreen 216 mg/mL

TopCare Everyday Kids Mineral Sunscreen is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by TOPCO ASSOCIATES LLC. The primary component is ZINC OXIDE.

Product Information

NDC	36800-0257
Product ID	36800-257_dbee4319-92d3-5773-e053-2a95a90aa7fe
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	TopCare Everyday Kids Mineral Sunscreen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	216
Active Ingredient Units	mg/mL
Substance Name	ZINC OXIDE
Labeler Name	TOPCO ASSOCIATES LLC
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 36800-0257-09 (36800025709)

Pricing Information	N/A
NDC Package Code	36800-257-09
Billing NDC	36800025709
Package	89 mL in 1 TUBE (36800-257-09)
Marketing Start Date	2020-12-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dbee42c8-9cae-7a81-e053-2a95a90a2329 Details

Active ingredients

Zinc Oxide 21.6%

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 value 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-sleeved shirts, pants, hats, and sunglasses

Other information

• protect the product in this container from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Inactive ingredients

water, C12-15 alkyl benzoate, caprylic/capric triglyceride, styrene/acrylates copolymer, octyldodecyl citrate crosspolymer, phenyl trimethicone, cetyl PEG/PPG-10/1 dimethicone, dimethicone, polyhydroxystearic acid, glycerin, ethyl methicone, cetyl dimethicone, silica, colloidal oatmeal, chrysanthemum parthenium (feverfew) flower/leaf/stem juice, glyceryl behenate, phenethyl alcohol, caprylyl glycol, bis-divinyl dimethicone PEG-10 dimethicone crosspolymer, sodium chloride, phenoxyethanol, chlorphenesin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPCARE EVERYDAY KIDS MINERAL SUNSCREEN

zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-257
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	216 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYL METHICONE (8 MPA.S) (UNII: 3YWG8XYT8H)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
OATMEAL (UNII: 8PI54V663Y)
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
TANACETUM PARTHENIUM FLOWER (UNII: 7TVV9D7I89)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-257-09	89 mL in 1 TUBE; Type 0: Not a Combination Product	12/02/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/02/2020

Labeler - TOPCO ASSOCIATES LLC (006935977)

Revised: 4/2022

Document Id: dbee4319-92d3-5773-e053-2a95a90aa7fe

Set id: dbee42c8-9cae-7a81-e053-2a95a90a2329

Version: 1

Effective Time: 20220405