FDA.reportPublic FDA data

Extreme Protect SPF 40

Manufacturer
Science of Skincare, LLC.
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:52:14

Label at a glance#

ProductExtreme Protect SPF 40 All Shades
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide: 15.3%

Titanium Dioxide: 1.3%

OTC - PURPOSE SECTION

Sunscreen

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 SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure.

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 skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10am - 2pm.

wear long-sleeve shirts, pants, hats, and sunglasses.

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

OTC - QUESTIONS SECTION

Call Customer Care at (888) 804 - 4447

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Zinc Oxide, C12-15 Alkyl Benzoate, Glycerin, Caprylic Capric Triglycerides, Tocopherol, Sorbitan Stearate, Panthenyl Triacetate, Titanium Dioxide, Pentylene Glycol, Ethyl Linoleate, Polyhydroxystearic Acid, Tribehenin, Polyurethane-62, Ethylhexylglycerin, Polyglyceryl-4 Isostearate, Hexyl Laurate, Cetyl PEG/PPG-10/1 Dimethicone, Butylene Glycol, Oleyl Alcohol, Xanthan Gum, Aluminum Stearate, Propylene Glycol, Asiaticoside, Asiatic Acid, Madecassic Acid, Alumina, Olea Europaea (Olive) Leaf Extract, Sorbitol/Sebacic Acid Copolymer Behenate, Magnesium Aluminum Silicate, Trideceth-6, Phenoxyethanol, Aloe Barbadensis Leaf Juice, Isostearic Acid, Disodium EDTA, Polyquaternium-7, +/- CI 77491, CI 77492, CI 77499 *May contain one or more of these ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

69219-108-21 5g 10 pack69219-108-21 5g 10 pack69219-108-01 Bronze 100g bottle69219-108-01 Bronze 100g bottle69219-108-11 Beige Box69219-108-11 Beige Box69219-108-01 Beige 100g bottle69219-108-01 Beige 100g bottle69219-108-01 NT 100g bottle69219-108-01 NT 100g bottle69219-108-02 5g single69219-108-02 5g single69219-108-11 NT Box69219-108-11 NT Box69219-108-11 Bronze 100g box69219-108-11 Bronze 100g box69219-108-0369219-108-0369219-108-3169219-108-31

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69219-108-01Extreme Protect SPF 40All Shades100 g in 1 BOTTLE, PLASTICCREAM1004
69219-108-02Extreme Protect SPF 40All Shades5 g in 1 BOTTLE, PLASTICCREAM54
69219-108-03Extreme Protect SPF 40All Shades240 g in 1 BOTTLE, PLASTICCREAM2404
69219-108-11Extreme Protect SPF 40All Shades1 in 1 BOXCREAM14
69219-108-21Extreme Protect SPF 40All Shades1 in 1 BAGCREAM14
69219-108-31Extreme Protect SPF 40All Shades1 in 1 BOXCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69219-108EXTREME PROTECT SPF 40 ALL SHADES (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [SCIENCE OF SKINCARE, LLC.]4Current NDC, Legacy NDC, 6 package rows20250112_b69db78b-5f0e-8ca2-e053-2a95a90ac88c.zip

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69219-10869219-108-01, 69219-108-11, 69219-108-02, 69219-108-21, 69219-108-03, 69219-108-31

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALOE VERA LEAFZY81Z83H0XIACT
POLYURETHANE-34 (40 MPA, TENSILE STRENGTH OF FILM AT BREAK)77KA3O6NNFIACT
WATER059QF0KO0RIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
XANTHAN GUMTTV12P4NEEIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ISOSTEARIC ACIDX33R8U0062IACT
EDETATE DISODIUM7FLD91C86KIACT
FERRIC OXIDE RED1K09F3G675IACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)0L414VCS5YIACT
GLYCERINPDC6A3C0OXIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
OLEYL ALCOHOL172F2WN8DVIACT
MADECASSIC ACIDM7O1N24J82IACT
DIMETHICONE 100RO266O364UIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
PANTHENOL TRIACETATE, (+)-1206E8961BIACT
ETHYL LINOLEATEMJ2YTT4J8MIACT
ASIATICOSIDEPKO39VY215IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
TOCOPHEROLR0ZB2556P8IACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
HEXYL LAURATE4CG9F9W01QIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PENTYLENE GLYCOL50C1307PZGIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
ALUMINUM STEARATEU6XF9NP8HMIACT
ALUMINUM OXIDELMI26O6933IACT
TRIDECETH-63T5PCR2H0CIACT
ZINC OXIDESOI2LOH54ZACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
ASIATIC ACID9PA5A687X5IACT
TRIBEHENIN8OC9U7TQZ0IACT
OLEA EUROPAEA LEAFMJ95C3OH47IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT

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
Extreme Protect SPF 40 All ShadesZINC OXIDE, TITANIUM DIOXIDEScience of Skincare, LLC.b69db78b-5f0e-8ca2-e053-2a95a90ac88c2025-01-09WarningsExact identifier
ndc (package): 69219-108-11
ndc (package): 69219-108-01
ndc (package): 69219-108-21
ndc (package): 69219-108-02
ndc (package): 69219-108-03
ndc (package): 69219-108-31
ndc (product): 69219-108
ndc11 (package): 69219010821
ndc11 (package): 69219010801
ndc11 (package): 69219010803
ndc11 (package): 69219010811
ndc11 (package): 69219010831
ndc11 (package): 69219010802
spl id: 2b4f67e8-6794-c22e-e063-6394a90ac9ac
spl set id: b69db78b-5f0e-8ca2-e053-2a95a90ac88c

Reported adverse events (FAERS/openFDA)#

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