Drug Facts
Drug Facts
Coppertone Glow Hydragel Spf 50 Gel
FDA Label NDC 66800-4473
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Beiersdort Inc for the product Coppertone Glow Hydragel Spf 50 (NDC 66800-4473). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Active Ingredients
Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9%
Purpose
Purpose
Sunscreen
Uses
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
Warnings
- For external use only
- Flammable. Keep away from fire or flame.
- 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
Directions
■ shake well before each 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
Other information
■ protect this product from excessive heat and direct sun
■ may stain or damage some fabrics or surfaces
Inactive Ingredients
Inactive ingredients SD alcohol 40-B (57.4% v/v), butyloctyl salicylate, dicaprylyl ether, ethylhexyl isononanoate, PVP, dimethicone/vinyl dimethicone crosspolymer, polyester-27, silica dimethicone silylate, acrylates/C12-22 alkyl methacrylate copolymer, calcium starch octenylsuccinate, fragrance, silica, synthetic fluorphlogopite, iron oxides
Questions
Questions? 1-866-288-3330
Principal Display Panel
Coppertone Sunscreen Gel
Glow Hydragel
SPF 50
Shimmery, Cool & Hydrating
Broad Spectrum SPF 50
Water Resistant (80 Minutes)
Free of oxybenzone, octinoxate, PABA & parabens
4.5 FL OZ (133 mL)
* Please review the disclaimer below.
