Total Sun Protection

Manufacturer
Cosmed Dermaceuticals, Inc. | Southeast Holdings Corp
Effective date
2025-11-11
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:43:22

Label at a glance#

ProductTotal Sun Protection
Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE
Label structure10 sections

Indications and 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 and administration

• 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 o...

Storage and handling

Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5% w/w

Octisalate 3.0% w/w

Oxybenzone 3.0% w/w

Zinc Oxide 4.0% w/w

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

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. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

Other Information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun

Questions or Comments:

OTC - QUESTIONS SECTION

Call 770-965-1022

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61352-004-01Total Sun Protection127.6 g in 1 BOTTLE, PLASTICLOTION127.67

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61352-00461352-004-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-12-08full-release2026-06-01 00:41:31

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Total Sun ProtectionOCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDECosmed Dermaceuticals, Inc.dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f2025-11-11WarningsExact identifier
ndc (package): 61352-004-01
ndc (product): 61352-004
ndc11 (package): 61352000401
spl id: 43545da6-6e83-7dc3-e063-6294a90ab889
spl set id: dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.