FDA.reportPublic FDA data

DR. MERCOLA Sunscreen SPF-50

Manufacturer
Pure Source, LLC
Effective date
2023-11-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:21:07

Label at a glance#

ProductDR. MERCOLA Sunscreen SPF-50
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions), sunscreen decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor. 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 10 a.m. - 2 p.m. Wear long-sleeve s...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide (6.0%) Zinc Oxide (22.5%)

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), sunscreen 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 product is swallowed get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Children under 6 months of age: Ask a doctor.
  • 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 10 a.m. - 2 p.m.
    • Wear long-sleeve shirts, pants, hats, and sunglasses
  • Re-apply:
    • After 40 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours

Other Information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Helanthus Annuus (Sunflower) Seed Oil, Lecithin, Glycerin, Cocos Nucifera (Coconut) Oil, Butyrospermum ParkII (Shea) Butter, Camellia Sinensis Leaf Extract, Xanthan Gum, Simmonds Chinensia (Jojoba) Seed Oil, Tocopherol, Glucurolactone, Eucalyptus Globulus Leaf Oil.

DR. MERCOLA Sunscreen SPF-50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Enter section text here SPF 50SPF 50

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z2
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP2
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z2
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7L2
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6622
GLUCONOLACTONEINACTIVE INGREDIENTWQ29KQ9POT2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B02
JOJOBA OILINACTIVE INGREDIENT724GKU717M2
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y2
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI2
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P82
WATERINACTIVE INGREDIENT059QF0KO0R2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE2

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65121-88665121-886-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SUNFLOWER OIL3W1JG795YIIACT
GLYCERINPDC6A3C0OXIACT
COCONUT OILQ9L0O73W7LIACT
SHEA BUTTERK49155WL9YIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
XANTHAN GUMTTV12P4NEEIACT
JOJOBA OIL724GKU717MIACT
TOCOPHEROLR0ZB2556P8IACT
GLUCONOLACTONEWQ29KQ9POTIACT
EUCALYPTUS OIL2R04ONI662IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 123 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEFILM, SOLUBLE / ORAL1 mgExact identifier — unii candidate
29 equally ranked IID candidates
SHEA BUTTERSHEA BUTTERK49155WL9YLOTION / TOPICAL2340 mgExact identifier — unii candidate
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOLUTION / TOPICAL15.5 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
29 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LCAPSULE, LIQUID FILLED / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE, COATED / ORAL0.25 mgExact identifier — unii candidate
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii candidate
29 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LAEROSOL, FOAM / TOPICAL23.6 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTINJECTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
6 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOZENGE / ORAL1264 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEAEROSOL, FOAM / TOPICAL0.27 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION/ DROPS / ORAL22 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTSPONGE / TOPICALADJ PHExact identifier — unii candidate
6 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / OPHTHALMIC2 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii candidate
29 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LOINTMENT / TOPICAL14.75 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, CHEWABLE, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
29 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8TABLET / ORAL0.08 mgExact identifier — unii candidate
5 equally ranked IID candidates

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
2b3fdfec-a5ff-2a90-e063-6394a90a39c45287fc39-6f0d-4b3c-8dd7-bfa949e69ee62025-01-09WarningsExact identifier
spl set id: 5287fc39-6f0d-4b3c-8dd7-bfa949e69ee6

Reported adverse events (FAERS/openFDA)#

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