SONNE Face Body Sunscreen SPF 30
SONNE Face Body Sunscreen SPF 30
355b266a-6623-76e7-e063-6394a90ab527
HUMAN OTC DRUG LABEL
May 17, 2025
CA Botana International INC
DUNS: 106276728
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sunscreen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (15)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Package Label principal display panel
INDICATIONS & USAGE SECTION
Indications & Usage
Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply: at least 2 hours. Children under 6 months: Ask a doctor. Sun protection measurements. 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 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. Protect this product from excessive heat and direct sun
EDIT
WARNINGS AND PRECAUTIONS SECTION
Warning and Precautions
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 product is swallowed, get medical help or contact a poison control center right away.
DOSAGE & ADMINISTRATION SECTION
Dosage & Administration
Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply: at least 2 hours. Children under 6 months: Ask a doctor. Sun protection measurements. 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 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. Protect this product from excessive heat and direct sun
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Zinc Oxide 19,2% Sunscreen
OTC - PURPOSE SECTION
Purpose
Sunscreen, helps prevent sunburn
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
For external use only.
Avoid contact with eyes.
Keep out of reach of children.
Do not apply to open wounds.
STOP USE AND ask a doctor if condition worsens or
symptoms persist for more than seven days, discontinue
use of the product.
WARNINGS SECTION
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 product is swallowed, get medical help or contact a poison control center right away.
INACTIVE INGREDIENT SECTION
Inactive ingredients
Butyloctyl Salicylate, Cetearyl Alcohol, Cetearyl Olivate, Coco- Caprylate/Caprate, Ethylhexylglycerin, Glycerin, Glyceryl Stearate SE
Phenoxyethanol, Polyhydroxystearic Acid, Sorbitan Olivate, Tocopheryl Acetate, Triethoxycaprylylsilane, Water/Aqua, Xanthan Gum.