FDA.reportPublic FDA data

Dragons Blood SPF15

Manufacturer
Rodial
Effective date
2024-01-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:06:58

Label at a glance#

ProductDragons Blood SPF15
Active ingredientHOMOSALATE, OCTINOXATE, OXYBENZONE
Label structure7 sections

Indications and uses

Helps prevent sunburn Higher SPF gives more sunburn protection

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...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 3%

Octinoxate 6%

Oxybenzone 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection

Warnings

WARNINGS SECTION

For external use only

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 and irritation develops and lasts.

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-sleeved shirts, pants, hats, and sunglasses.
• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating”

Other informations

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua/Water/Eau, Glycerin, Propylene Glycol, Cyclopentasiloxane, Dimethicone, Niacinamide, Phenoxyethanol, Polysilicone-11, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Benzyl Alcohol, Squalane, Parfum (Fragrance), Limonene, Ethylhexyl Cocoate, Hydrolyzed Caesalpinia Spinosa Gum, Dimethiconol, Ethylhexylglycerin, Sodium Hyaluronate, Polysorbate 60, Geraniol, Caesalpinia Spinosa Gum, Citronellol, Dehydroacetic Acid, Croton Lechleri Resin Extract, Linalool, Sorbitan Isostearate, Dimethylmethoxy Chromanyl Palmitate, Potassium Sorbate, Sodium Benzoate, Disodium EDTA, Citral, Ceratonia Siliqua
(Carob) Seed Extract, Farnesol, Hydroxycitronellal, Sorbic Acid.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package0Outer Package0Inner Package0Inner Package0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52456-025-01Dragons Blood SPF151 in 1 CARTONCREAM13
52456-025-01Dragons Blood SPF1550 mL in 1 TUBECREAM503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52456-025DRAGONS BLOOD SPF15 (OCTINOXATE, HOMOSALATE, OXYBENZONE) CREAM [RODIAL]32 package rows20240111_71b5ec12-73b1-494b-b05b-b55c538e43bc.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52456-02552456-025-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYALURONATE SODIUMYSE9PPT4THIACT
POLYSORBATE 60CAL22UVI4MIACT
GERANIOLL837108USYIACT
CAESALPINIA SPINOSA RESINWL3883U2POIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
DEHYDROACETIC ACID2KAG279R6RIACT
CROTON LECHLERI RESINGGG6W25C63IACT
LINALOOL, (+/-)-D81QY6I88EIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
DIMETHYLMETHOXY CHROMANYL PALMITATE5G222ZDK7UIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
CITRALT7EU0O9VPPIACT
CAROB5MG5Z946UOIACT
FARNESOLEB41QIU6JLIACT
HYDROXYCITRONELLAL8SQ0VA4YURIACT
SORBIC ACIDX045WJ989BIACT
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
NIACINAMIDE25X51I8RD4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
TROLAMINE9O3K93S3TKIACT
BENZYL ALCOHOLLKG8494WBHIACT
SQUALANEGW89575KF9IACT
LIMONENE, (+)-GFD7C86Q1WIACT
ETHYLHEXYL COCOATEI1MPW273QSIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
0e892178-1620-bfab-e063-6294a90a6b4871b5ec12-73b1-494b-b05b-b55c538e43bc2024-01-09WarningsExact identifier
spl id: 0e892178-1620-bfab-e063-6294a90a6b48
spl set id: 71b5ec12-73b1-494b-b05b-b55c538e43bc

Reported adverse events (FAERS/openFDA)#

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