Drugplain

Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 3 g/100g

Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9% · LOTION · Beiersdorf Inc

No Recall History
Plain English

Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 is a lotion containing avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% at 3 g/100g, taken topical. Manufactured by Beiersdorf Inc.

Key Facts

Brand Name
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50
Generic Name
Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9%
NDC Code (Product)
66800-4839
Manufacturer
Beiersdorf Inc
Strength
3 g/100g
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
12/29/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

sepsis2 reports
abdominal abscess1 reports
abscess1 reports
blood magnesium decreased1 reports
bradycardia1 reports
candida infection1 reports
candida test positive1 reports
diarrhoea1 reports
encephalopathy1 reports
enterococcus test positive1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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

Warnings

Warnings For external use only Flammable: Do not use near heat, flame, or while smoking

Frequently Asked Questions

What is Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 used for?

Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 contains Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9%. It is a lotion taken topical. Consult your doctor for specific uses.

Is Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 a controlled substance?

Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 is not classified as a controlled substance by the DEA.

What is the generic name for Coppertone Waterbabies Pure and Simple Sunscreen SPF 50?

The generic name for Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 is Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9%. There are 7 other brand versions of Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9%.

What is the NDC code for Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 3 g/100g?

The NDC (National Drug Code) for Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 3 g/100g is 66800-4839, listed by Beiersdorf Inc.