Drugplain

HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50 3 g/100mL

AVOBENZONE, Homosalate OCTISALATE, · CREAM · NAKED SUNDAYS PTY LTD

No Recall History
Plain English

HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50 is a cream containing avobenzone, homosalate octisalate, at 3 g/100mL, taken topical. Manufactured by NAKED SUNDAYS PTY LTD.

Key Facts

Brand Name
HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50
Generic Name
AVOBENZONE, Homosalate OCTISALATE,
NDC Code (Product)
81104-802
Manufacturer
NAKED SUNDAYS PTY LTD
Strength
3 g/100mL
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
06/30/2023

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

USES Use: Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin ageing caused by the sun.

Dosage & Administration

DIRECTIONS SPRAY 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE. Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying. Reapply at least every 2 hours. Children under 3 years of age: Ask a doctor. 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 10.00AM - 2.00PM Wear long-sleeved shirts, pants, hats, and sunglasses

Warnings

WARNINGS Warnings: For external use only. Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. 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. Use a water-resistant sunscreen if swimming or sweating Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS SPRAY 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE. Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying. Reapply at least every 2 hours. Children under 3 years of age: Ask a doctor. 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 me

Frequently Asked Questions

What is HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50 used for?

HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50 contains AVOBENZONE, Homosalate OCTISALATE,. It is a cream taken topical. Consult your doctor for specific uses.

Is HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50 a controlled substance?

HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50 is not classified as a controlled substance by the DEA.

What is the generic name for HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50?

The generic name for HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50 is AVOBENZONE, Homosalate OCTISALATE,. There are 2 other brand versions of AVOBENZONE, Homosalate OCTISALATE,.

What is the NDC code for HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50 3 g/100mL?

The NDC (National Drug Code) for HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50 3 g/100mL is 81104-802, listed by NAKED SUNDAYS PTY LTD.

Product NDC

81104-802

Package NDC

81104-802-01

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)