FDA.reportPublic FDA data

Ultimate Protection SPF28

Manufacturer
Face Reality Skin Care, LLC | Island Kinetics d.b.a. CoValence Laboratories
Effective date
2024-12-09
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 20:47:11

Label at a glance#

ProductUltimate Protection SPF28
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure8 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. • Use a water resistant sunscreen if swimming or sweating. • Reapply 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, especi...

Label contents#

Full prescribing information#

Active Ingredient(s):

OTC - ACTIVE INGREDIENT SECTION


11.6% Zinc Oxide, 0.67% Titanium Dioxide

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

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product 

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if rash occurs.

Keep out of reach of children. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

• Apply liberally 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply 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 a.m.-2 p.m. Wear long-sleeve shirts, pants, hats and sunglasses.
• Children under 6 months: Ask a doctor.

Other Information:

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aqua (Water), Caprylic/Capric Triglyceride, Ceteryl Alcohol, Cetearyl Glucoside, Coco-Caprylate/Caprate, Polysorbate 60, Glycerin, Squalane, Polyglyceryl-6 Polyricinoleate, Isononyl Isononanoate, Magnesium Aluminum Silicate, Xanthan Gum, Glyceryl Isostearate, Polyhydroxystearic Acid, Alumina, Tocopherol (D-alpha), Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Juice Powder*, Simethicone, Fructooligosaccharides (D-Beta), Allantoin, Potassium Sorbate, Trisodium Ethylenediamine Disuccinate, Citric Acid, Populus Temuloides Bark Extract, Leuconostoc/Radish Root Ferment Filtrate, Dicaprylyl Ether, 1,2 Hexanediol, Caprylyl Glycol, Gluconolactone, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Tropolone

QUESTIONS

OTC - QUESTIONS SECTION

1.866.477.3077

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New LabelNew Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70707-619ULTIMATE PROTECTION SPF28 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [FACE REALITY SKIN CARE, LLC]8Legacy NDC20241210_3d337e26-2ee2-175e-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70707-61970707-619-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
POLYSORBATE 60CAL22UVI4MIACT
GLYCERINPDC6A3C0OXIACT
SQUALANEGW89575KF9IACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
ALUMINUM OXIDELMI26O6933IACT
TOCOPHEROLR0ZB2556P8IACT
SUNFLOWER OIL3W1JG795YIIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALLANTOIN344S277G0ZIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
DICAPRYLYL ETHER77JZM5516ZIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLUCONOLACTONEWQ29KQ9POTIACT
TROPOLONE7L6DL16P1TIACT
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
28d7f900-f8a7-db88-e063-6394a90a5a1c3d337e26-2ee2-175e-e054-00144ff8d46c2024-12-09WarningsExact identifier
spl id: 28d7f900-f8a7-db88-e063-6394a90a5a1c
spl set id: 3d337e26-2ee2-175e-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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