Private Label SPF 50 80 min Water Resistant HOMOSALATE OCTISALATE ZINC OXIDE SUNSCREEN SWISS-AMERICAN CDMO, LLC FDA Approved Uses Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
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Substance Homosalate
Route
TOPICAL
Applications
M020
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients Homosalate 10.0% Sunscreen Octisalate 5.0% Zinc Oxide 16.5% Sunscreen
Inactive Ingredients
Inactive Ingredients C15-19 Alkane Calcium gluconate citric acid dimethicone disodium EDTA disteardimonium hectorite ethylhexylglycerin gluconolactone Gossypium hirsutum (cotton) extract glycerin glyceryl behenate hydrogenated polyisobutene lecithin octyldodecyl neopentanoate phenoxyethanol polyglyercyl-2 isostearate polyglyceryl-6 polyricinoleate polyhydroxystearic acid polysilicone-11 pullulan saccharide isomerate sclerotium gum silica sodium benzoate sodium chloride sodium citrate sodium hydroxide sodium olivate tocopherol tocopheryl acetate triethoxycaprylysilane xanthan gum water
Strengths
10.0 % 5.0 % 16.5 %
Treats Conditions
Uses Helps Prevent Sunburn If Used As Directed With Other Sun Protection Measure See Directions Decreases The Risk Of Skin Cancer And Early Skin Aging Caused By The Sun

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
V06SV4M95S 4X49Y0596W SOI2LOH54Z
Packaging

Labeling B-PL035 Artwork

Package Descriptions
  • Labeling B-PL035 Artwork

Overview

Uses Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Indications & Usage

Uses Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage & Administration

Directions Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Warnings & Precautions
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 physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.
Purpose

Uses Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN

Questions

Questions? Call toll free 1-866-416-2366


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