TOPCARE EVERYDAY KIDS MINERAL SUNSCREEN- zinc oxide lotion 
TOPCO ASSOCIATES LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TopCare Everyday Kids Mineral Sunscreen Lotion

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

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

• 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

TOP48147A

TOPCARE EVERYDAY KIDS MINERAL SUNSCREEN 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-257
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION216 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-257-0989 mL in 1 TUBE; Type 0: Not a Combination Product12/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/02/2020
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
 
TOPCO ASSOCIATES LLC