Label: TOPCO TOPCARE EVERYDAY MINERAL SUNSCREEN ZINC OXIDE SPF 50- zinc oxide lotion
- NDC Code(s): 36800-251-09
- Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 7, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
-
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
-
Inactive ingredients
water, C12-15 alkyl benzoate, caprylic/capric triglyceride, styrene/acrylates copolymer, octydodecyl citrate crosspolmyer, phenyl trimethicone, cetyl PEG/PPG-10/1 dimethicone, dimethicone, glycerin, polyhydroxystearic acid, ethyl methicone, cetyl dimethicone, silica, 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
TOPCO TOPCARE EVERYDAY MINERAL SUNSCREEN ZINC OXIDE SPF 50
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-251 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 216 mg in 1 mL Inactive Ingredients Ingredient Name Strength PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) GLYCERYL MONOBEHENATE (UNII: A626UU0W2A) SODIUM CHLORIDE (UNII: 451W47IQ8X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERIN (UNII: PDC6A3C0OX) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) DIMETHICONE (UNII: 92RU3N3Y1O) TANACETUM PARTHENIUM FLOWER (UNII: 7TVV9D7I89) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) WATER (UNII: 059QF0KO0R) ETHYL METHICONE (8 MPA.S) (UNII: 3YWG8XYT8H) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-251-09 89 mL in 1 TUBE; Type 0: Not a Combination Product 12/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 12/02/2020 Labeler - TOPCO ASSOCIATES LLC (006935977)
