Homosalate, Octisalate, Zinc Oxide Lotion
FDA Label NDC 76162-957

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Homosalate, Octisalate, Zinc Oxide (NDC 76162-957). 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 claims, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Claims

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Disclaimers

→ Adverse Reactions

→ Top Panel And Side Panel Claims

→ Principal Display Panel

Claims

Top Care ^® beauty

Morning Facial Moisturizing Lotion

Active Ingredients

Homosalate 10%

Octisalate 5%

Zinc Oxide 6.3%

Purpose

Sunscreen

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

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply liberally {and evenly} 15 minutes before sun exposure
apply to all skin exposed to the sun
reapply at least every 2 hours
use a water resistant sunscreen if swimming or sweating
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-sleeved shirts, pants, hats and sunglasses
children under 6 months of age: Ask a doctor

Other Information

protect the product in this container from excessive heat and direct sun

Inactive Ingredients

water, glycerin, cetearyl alcohol, niacinamide, behentrimonium methosulfate, dimethicone, ceramide NP, ceramide AP, ceramide EOP, carbomer, triethoxycaprylylsilane, chlorphenesin, sodium lauroyl lactylate, cholesterol, aluminum starch octenylsuccinate, disodium EDTA, sodium hydroxide, benzyl alcohol, hydroxyethylcellulose, sodium hyaluronate, phytosphingosine, xanthan gum

Questions Or Comments?

Call 1-888-423-0139

Disclaimers

May stain or damage some fabrics or surfaces.

*This product is not manufactured or distributed by L’Oreal USA S/D, Inc., distributor of CeraVe ^® AM Facial Moisturizing Lotion with Sunscreen Broad Spectrum SPF 30.