Total Sun Protection OCTINOXATE OCTISALATE OXYBENZONE ZINC OXIDE COSMED DERMACEUTICALS, INC. FDA Approved 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

TOTAL SUN PROTECTION

Generic: OCTINOXATE OCTISALATE OXYBENZONE ZINC OXIDE
Mfr: COSMED DERMACEUTICALS, INC. FDA OTC
FunFoxMeds box
Substance Octinoxate
Route
TOPICAL
Applications
M020
Product NDC
61352-0004-00 61352-0004-01
Package NDC
61352-004-01

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients Octinoxate 7.5% w/w Octisalate 3.0% w/w Oxybenzone 3.0% w/w Zinc Oxide 4.0% w/w
Inactive Ingredients
Inactive Ingredients Water PPG-3 Myristyl Ether Aloe Barbadensis Leaf Extract Glycol Stearate Cetyl Alcohol Polyacrylamide PVP/Hexadecene Copolymer White Tea (Camellia Oleisera) Leaf Extract Green Tea (Camellia Sinensis) Leaf Extract Tocopheryl Acetate Propylene Glycol C13-14 Isoparaffin Decyl Glucoside Silica Cetyl Phosphate Glyceryl Stearate PEG 100 Stearate Glycerin Diazolidinyl Urea Triethoxycaprylylsilane Methylparaben Disodium EDTA Propylparaben Laureth-7
Strengths
7.5 % 3.0 % 4.0 %
Treats Conditions
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

Identifiers & Packaging

Container Type UNKNOWN
NDC 61352-0004-00
All Product Codes
61352-0004-00 61352-0004-01
UNII
4Y5P7MUD51 4X49Y0596W 95OOS7VE0Y SOI2LOH54Z
SPL Set IDs
dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f
Packaging

Label

Package Descriptions
  • Label
Overview

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

Indications & Usage

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

Dosage & Administration

Directions • Apply liberally 15 minutes before sun exposure and as needed • Reapply: • After 40 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 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 10am to 2pm • Wear long sleeve shirts, pants, hats, and sun glasses • Children under 6 months: Ask a doctor

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 doctor if rash occurs. Keep out of reach of children. If product is swalled, get medical help or contact a Poison Control Center right away.
Purpose

Purpose Sunscreen

Keep Out of Reach of Children

Keep out of reach of children.

Storage & Handling

Other Information Protect this product from excessive heat and direct sun

Questions

Questions or Comments: Call 770-965-1022

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Additional Information

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