Label: COPPERTONE PURE AND SIMPLE SUNSCREEN SPF 50- zinc oxide 24.08% aerosol, spray
- NDC Code(s): 66800-4744-5, 66800-4744-6, 66800-4744-7
- Packager: Beiersdorf Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 11, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Use
- Warnings
- DO NOT USE
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DO NOT USE
■ keep away from face to avoid breathing it
■ keep out of eyes. Rinse with water to remove.
■ use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
■ do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120˚F.
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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Directions
■ shake well before each use
■ spray liberally and spread evenly by hand 15 minutes before sun exposure
■ hold container 4 to 6 inches from the skin to apply
■ do not spray directly into face. Spray on hands then apply to face.
■ do not apply in windy conditions
■ use in a well-ventilated area
■ 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
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Inactive Ingredients
isobutane, 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, tea (camellia sinensis) leaf extract*, giant kelp (macrocystis pyrifera) extract*, sacred lotus (nelumbo nucifera) extract*, triethoxycaprylylsilane, beeswax, hydroxyacetophenone, PEG-12 dimethicone crosspolymer, tocopherol, 1,2-hexanediol, caprylyl glycol, caprylyl methicone, sodium chloride, cetyl dimethicone
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COPPERTONE PURE AND SIMPLE SUNSCREEN SPF 50
zinc oxide 24.08% aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-4744 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 240.8 mg in 1 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) POLYESTER-7 (UNII: 0841698D2F) ISOBUTANE (UNII: BXR49TP611) WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) SYNTHETIC BEESWAX (UNII: 08MNR5YE2R) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) SODIUM CHLORIDE (UNII: 451W47IQ8X) TOCOPHEROL (UNII: R0ZB2556P8) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) NELUMBO NUCIFERA LEAF (UNII: 60C608DPVT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETYL DIMETHICONE 150 (UNII: 5L694Y0T22) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66800-4744-5 142 g in 1 CAN; Type 0: Not a Combination Product 01/01/2021 2 NDC:66800-4744-6 142 g in 1 CAN; Type 0: Not a Combination Product 01/01/2021 3 NDC:66800-4744-7 142 g in 1 CAN; Type 0: Not a Combination Product 01/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/01/2021 Labeler - Beiersdorf Inc (001177906)