OTC Medication Information: Coppertone Sport Mineral Sunscreen SPF 50

COPPERTONE SPORT MINERAL SUNSCREEN SPF 50- zinc oxide lotion
Beiersdorf Inc

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 Facts

Drug Facts

Active Ingredient

Active Ingredient

Zinc Oxide 24.08%

Purpose

Purpose -Sunscreen

Use

Use — helps prevent sunburn

Warnings

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 product is swallowed, get medical help or contac a Poison Control Center right away.

Directions

Directions

• ​shake well before use
• apply liberally 15 minutes before sun exposure
• reapply:
  • ​after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • 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, expecially from 10 a.m. — 2 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months: Ask a doctor

Other Information

Other information

• protect this product from excessive heat and direct sun
• may stain or damage some fabrics or surfaces

Inactive Ingredients

Inactive ingredients water, C12-15 alkyl benzoate, isopropyl palmitate, butyloctyl salicylate, ethylhexyl isononanoate, cetyl PED-PPG-10/1 dimethicone, propylene glycol, cyclopentasilxane, bis-octyldodecyl dimer dilinoleate/propanediol copolymer, dimethicone, ethylhexyl methoxycrylene, polyester-27, triethoxycaprylylsilane, beeswax, hydroxyacetophenone, sodium chloride, PEG-12 dimethicone crosspolymer, 1,2-hexanediol, caprylyl glycol

Questions

Questions? 1-866-288-3330

Package Display

Coppertone®

SUNSCREEN LOTION

SPORT MINERAL

SPF 50

100% naturally sourced zinc-oxide

Free of oxybenzone, oxtinoxate, PABA, parabens, phthalate

Water Resistant (80 minutes)

Broad Spectrum SPF 50

5 FL OZ (148 mL)

COPPERTONE SPORT MINERAL SUNSCREEN SPF 50 zinc oxide lotion

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-0002 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 240.8 mg in 1 mL

Inactive Ingredients Ingredient Name Strength POLYESTER-7 ISOPROPYL PALMITATE ETHYLHEXYL METHOXYCRYLENE BUTYLOCTYL SALICYLATE WATER ETHYLHEXYL ISONONANOATE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) CAPRYLYL GLYCOL TRIETHOXYCAPRYLYLSILANE SYNTHETIC BEESWAX CYCLOMETHICONE 5 HYDROXYACETOPHENONE SODIUM CHLORIDE PEG-12 DIMETHICONE 1,2-HEXANEDIOL PROPYLENE GLYCOL ALKYL (C12-15) BENZOATE BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER DIMETHICONE

Product Characteristics Color yellow ((Off white to light yellow)) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:66800-0002-5 148 mL in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/02/2020

Labeler — Beiersdorf Inc (001177906)

Revised: 03/2023 Beiersdorf Inc