OTC Medication Information: Coppertone Kids Roll-On Sunscreen SPF 50

COPPERTONE KIDS ROLL-ON 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

Active ingredient

Zinc Oxide 24.08%

Purpose

Sunscreen

Use

■ helps prevent sunburn

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 contact a Poison Control Center right away.

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, especially from 10 a.m. – 2 p.m.

■ wear long-sleeve shirts, pants, hats, and sunglasses

■ children under 6 months: Ask a doctor

Other information

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

Inactive ingredients

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

Questions?

1-866-288-3330

Fun Roll-On

Coppertone _®

Zinc Oxide Sunscreen Lotion

#1 Pediatrician Recommended Sunscreen Brand

Kids with Blue Color

Tear Free

50

100% Mineral Sun Protection*

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

Stays on strong, even in water

COPPERTONE KIDS ROLL-ON SUNSCREEN SPF 50 zinc oxide 24.08% lotion

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-4026 Route of Administration SUPRACHOROIDAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 24.08 g in 100 g

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

Product Characteristics Color blue Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:66800-4026-2 75 g in 1 CANISTER None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2023

Labeler — Beiersdorf Inc (001177906)

Revised: 02/2023 Beiersdorf Inc