FDA.reportPublic FDA data

SPF 50 Moisturizing Sunscreen Broad Spectrum

Manufacturer
GATE THERAPEUTICS
Effective date
2022-11-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:51:58

Label at a glance#

ProductSPF 50 Moisturizing Sunscreen Broad Spectrum
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                            Purpose

Octinoxate 6%, Zinc Oxide 12%       Sunscreen

OTC - PURPOSE SECTION

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.

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.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

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.

DOSAGE & ADMINISTRATION SECTION

Directions
• Apply liberally 15 minutes before sun exposure

• Reapplyat least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• 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 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10a.m. – 2p.m.
• Wear long-sleeve shirts, pants, hats, and sunglasses
• Children under six months consult a physician

INACTIVE INGREDIENT SECTION

Inactive ingredients   ​ ​Water, Polysorbate 60, Coconut Alkanes, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Cetearyl Alcohol, Glycerin, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Bisabolol, Coffea Arabica (Coffee) Seed Oil, Pentylene Glycol, Tetrahexyldecyl Ascorbate, Xanthophyll, Ascorbyl Palmitate, Tocopherol, Beta-Carotene, Coco-Caprylate/Caprate, Folic Acid, Carthamus Tinctorius (Saffower) Seed Oil, Solanum Lycopersicum (Tomato) Seed Oil, Tocopheryl Acetate, Vaccinium Myrtillus (Bilberry) Fruit Extract, Argania Spinosa Kernel Oil, Dimethicone, Dipotassium Phosphate, Hydrogenated Lecithin, Potassium Phosphate, Zea Mays (Corn) Oil, Polyhydroxystearic Acid, Alcohol, Butylene Glycol, Xanthan Gum, Disodium EDTA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Citric Acid, Dehydroacetic Acid, Benzyl Alcohol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF 50+

Moisturizing Sunscreen

Broad Spectrum Daily Use

1Fl Oz/30 mL

Tube 1 ozTube 1 oz

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72274-002-012024-01-30C16284748780-11030e365-3c32-111a-e063-dadaa90a10e2SPF 50 Moisturizing Sunscreen
72274-002-022024-01-30C16284748780-11030e365-3c32-111a-e063-dadaa90a10e2SPF 50 Moisturizing Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72274-002-01SPF 50 Moisturizing Sunscreen Broad Spectrum30 mL in 1 TUBELOTION303
72274-002-02SPF 50 Moisturizing Sunscreen Broad Spectrum90 mL in 1 TUBELOTION903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72274-002SPF 50 MOISTURIZING SUNSCREEN BROAD SPECTRUM (OCTINOXATE, ZINC OXIDE) LOTION [GATE THERAPEUTICS]3Legacy NDC, 2 package rows20221202_48013b2c-d398-42fc-ab1d-b628d1a3993d.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
72274-00272274-002-01, 72274-002-02

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
WATER059QF0KO0RIACT
POLYSORBATE 60CAL22UVI4MIACT
COCONUT ALKANES1E5KJY107TIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
LEVOMENOL24WE03BX2TIACT
ARABICA COFFEE OILIK55HKE887IACT
PENTYLENE GLYCOL50C1307PZGIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
LUTEINX72A60C9MTIACT
ASCORBYL PALMITATEQN83US2B0NIACT
TOCOPHEROLR0ZB2556P8IACT
.BETA.-CAROTENE01YAE03M7JIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
FOLIC ACID935E97BOY8IACT
SAFFLOWER OIL65UEH262ISIACT
TOMATO SEED OIL7N87T9C06TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BILBERRY9P2U39H18WIACT
ARGAN OIL4V59G5UW9XIACT
DIMETHICONE92RU3N3Y1OIACT
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
POTASSIUM PHOSPHATE, MONOBASIC4J9FJ0HL51IACT
CORN OIL8470G57WFMIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ALCOHOL3K9958V90MIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
XANTHAN GUMTTV12P4NEEIACT
EDETATE DISODIUM7FLD91C86KIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DEHYDROACETIC ACID2KAG279R6RIACT
BENZYL ALCOHOLLKG8494WBHIACT
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
eeb600a3-8850-2cd7-e053-2a95a90ac0b748013b2c-d398-42fc-ab1d-b628d1a3993d2022-11-30WarningsExact identifier
spl id: eeb600a3-8850-2cd7-e053-2a95a90ac0b7
spl set id: 48013b2c-d398-42fc-ab1d-b628d1a3993d

Reported adverse events (FAERS/openFDA)#

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