TOPCARE EVERYDAY MINERAL SUNSCREEN ZINC OXIDE SPF 30- 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 Mineral Sunscreen Lotion Zinc Oxide SPF 30

Active ingredients

Zinc Oxide 18.24%

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, styrene/acrylates copolymer, caprylic/capric triglyceride, dimethicone, phenyl trimethicone, cetyl PEG/PPG-10/1 dimethicone, polyhydroxystearic acid, glycerin, dipropylene glycol dibenzoate, cetyl dimethicone, silica, chrysanthemum parthenium (feverfew) flower/leaf/stem juice, glyceryl behenate, phenethyl alcohol, caprylyl glycol, acrylates/dimethicone crosspolymer, PPG-15 stearyl ether benzoate, sodium chloride, phenoxyethanol, chlorphenesin

TOP48145A

TOPCARE EVERYDAY MINERAL SUNSCREEN ZINC OXIDE SPF 30 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-260
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION182.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)  
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)  
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)  
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:36800-260-0989 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: dbf03701-d160-130c-e053-2a95a90a19b8
Set id: dbf03882-ab1a-9805-e053-2995a90a7109
Version: 1
Effective Time: 20220405
 
TOPCO ASSOCIATES LLC