Zinc Oxide 20.00% Lotion
FDA Label NDC 85033-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Coconut Caliente Costa Rica Llc for the product Zinc Oxide 20.00% (NDC 85033-001). 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 active ingredient                    purpose, uses, directions, warnings for external use only., keep out of reach of children, ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                    Purpose

Zinc Oxide 20% ......................Sunscreen

Uses

Helps prevent sunburn

Directions

Apply evenly to face and neck 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
10a.m.– 2p.m. . Wear long-sleeve shirts, pants, hats, and sunglasses.
. Children under 6 months: Ask a doctor.

Warnings For External Use Only.

Do not useon damaged or broken skin.
When using this product• keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor ifrash occurs.

Keep Out Of Reach Of Children

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

Ingredients

1,2-Hexancdiol
Aloc Barbadcnsis Lcaf Extract
Aloe Barbadensis Leaf Juice
Ascorhvl Palmitate
Butylcnc Glycol
Butyloctyl Salicylate
ButyrosDerrnum Parkii (Shea) Butler
Caprylic/Capric Triglivceride
Cetearvl Olivate
Daucus Carota Sativa (Carrot) Rioot Extract
Dicaprylyl Carbonatc
Dimethicone
Ethylhexyl Methoxycrvlene
.bthylhexylglvccrin
Iragrancc
Helianthus Amuus (Sunllorver) Seed Oil
Hydrogcnatecl Castor Oil
Isoplorryl N,lyristate
Magncsium Sulfate
Mansifera lndica (Mar.rgo) Seed Butter
Mineral Oil
Niacinamiclc
Phenoxyethanol
Phospholipids
Polvslvceiryl-3 .Polyr icinoleate
Polyhydroxystearic Acid
Rctinyl Palmitate
Ilubus ldaeus (Red Raspbern) Seccl Oil
Sodiunr llyaluronate
Sorbitan Olcate
Sorbitan Olivate
Synthctic Bccsu,ax
Tocopheryl Acetate
VP/Hexadecene Copolymer
Water
Xanthan Gum

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