FDA.reportPublic FDA data

SUNSHIELD

Manufacturer
CLINICAL CARE SKIN SOLUTIONS, INC
Effective date
2023-02-21
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:54:11

Label at a glance#

ProductSUNSHIELD SPF-30
Active ingredientOCTINOXATE, OCTISALATE, ZINC OXIDE
Label structure6 sections

Indications and uses

HELPS PREVEN SUNBURN

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE 6.9%, OCTISALATE 3%, ZINC OXIDE 4%

USES:

INDICATIONS & USAGE SECTION

HELPS PREVEN SUNBURN

WARNINGS:

WARNINGS SECTION

SKIN CANCER/SKIN AGING ALERT: SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY AGING SKIN. THIS PRODUCT HAS BEEN SLOWN ONLY TO PREVEN SUNBURN, NOT SKIN CANCER OR EALY SKIN AGING.

  • 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.
  • REAPPLY EVERY 40 MINUTES.
  • STOP USE AND ASK DOCTOR IF RASH OCCURS. 

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

WATER, ALOE BARBADENSIS LEAF JUICE, GLYCERIN, PROPYLENE GLYCOL, ISOPROPYL PALMITATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CYCLOMETHICONE, CETEARYL ALCOHOL, CETEARETH-2, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, VP/EICOSENE COPOLYMER, SQUALANE, BUTYROSPERMUM PARKII (SHEA) BUTTER, PERSEA GRATISSIMA (AVOCADO) OIL, IMIDAZOLIDINYL UREA, METHYLPARABEN, TOCOPHERYL ACETATE, POLYSORBATE 60, FRAGRANCE, DISODIUM EDTA, PROPYLPARABEN, TRIETHOXYCAPRYLYLSYLANE, RETINYL PALMITATE, CITRIC ACID.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sunshield SPF-30_UCSunshield SPF-30_UC

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70900-202-542025-01-30C16284748780-12cef2736-ab3e-d83d-e063-dadaa90ab31fCLINICAL CARE SKIN SOLUTIONS - SUNSHIELD (70900-202)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70900-202-14SUNSHIELDSPF-30120 mL in 1 BOTTLECREAM1207
70900-202-54SUNSHIELDSPF-301 in 1 BOXCREAM17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70900-202SUNSHIELD SPF-30 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [CLINICAL CARE SKIN SOLUTIONS, INC]7Legacy NDC, 2 package rows20230222_e20506af-5801-4e11-b963-52916afbda01.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70900-20270900-202-14, 70900-202-54

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CYCLOMETHICONENMQ347994ZIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
SQUALANEGW89575KF9IACT
SHEA BUTTERK49155WL9YIACT
AVOCADO OIL6VNO72PFC1IACT
IMIDUREAM629807ATLIACT
METHYLPARABENA2I8C7HI9TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYSORBATE 60CAL22UVI4MIACT
EDETATE DISODIUM7FLD91C86KIACT
PROPYLPARABENZ8IX2SC1OHIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

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
f53a1288-c619-4103-e053-2a95a90a8904e20506af-5801-4e11-b963-52916afbda012023-02-21WarningsExact identifier
spl id: f53a1288-c619-4103-e053-2a95a90a8904
spl set id: e20506af-5801-4e11-b963-52916afbda01

Reported adverse events (FAERS/openFDA)#

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