FDA.reportPublic FDA data

Sunscreen with Aloe Vera SPF 30

Manufacturer
Body One Products, Inc. | BMC 1092,Inc dba Solo Laboratories Inc.
Effective date
2020-01-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:03:37

Label at a glance#

ProductSunscreen with Aloe Vera SPF 30
Active ingredientOctinoxate, Octisalate, Oxybenzone
Label structure9 sections

Indications and uses

* Helps prevent sunburn

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. * Children under 6 months: ask a Doctor.

Storage and handling

Protect this product container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Octinoxate 7.5%Sunscreen
Octisalate 5.0%Sunscreen
Oxybenzone 6.0%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

SPL UNCLASSIFIED SECTION

For external use only

OTC - DO NOT USE SECTION

Do Not Use on damaged skin 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 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.
  • Children under 6 months: ask a Doctor.

Other Information

STORAGE AND HANDLING SECTION

Protect this product container from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Brassica Campestris/Aleurites Fordi Oil Copolymer, Butyl Paraben, Carbomer, Dimethicone, Ethylparaben, Fragrance,Glyceryl Stearate SE, Isobutylparaben, Lanolin Alcohol, Methylparaben,Mineral Oil, Phenoxyethanol, Propylparaben, Stearic Acid , Water.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-800-544-8800

PRINCIPAL DISPLAY PANEL - 532 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BodyOne
Products

SUN SCREEN

SPF 30 LOTION

(18 FL.OZ. 532ML)

Principal Display Panel - 532 ML Bottle Label
Principal Display Panel - 532 ML Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73563-011-012025-01-30C16284748780-11030e365-1988-111a-e063-dadaa90a10e2Sunscreen with Aloe Vera SPF 30
73563-011-182025-01-30C16284748780-11030e365-1988-111a-e063-dadaa90a10e2Sunscreen with Aloe Vera SPF 30
73563-011-012024-09-20C16284748780-11030e365-1988-111a-e063-dadaa90a10e2Sunscreen with Aloe Vera SPF 30
73563-011-182024-09-20C16284748780-11030e365-1988-111a-e063-dadaa90a10e2Sunscreen with Aloe Vera SPF 30
73563-011-012024-07-30C16284748780-11030e365-1988-111a-e063-dadaa90a10e2Sunscreen with Aloe Vera SPF 30
73563-011-182024-07-30C16284748780-11030e365-1988-111a-e063-dadaa90a10e2Sunscreen with Aloe Vera SPF 30
73563-011-012024-01-30C16284748780-11030e365-1988-111a-e063-dadaa90a10e2Sunscreen with Aloe Vera SPF 30
73563-011-182024-01-30C16284748780-11030e365-1988-111a-e063-dadaa90a10e2Sunscreen with Aloe Vera SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73563-011-01Sunscreen with Aloe Vera SPF 303785 mL in 1 JUGLOTION37851
73563-011-18Sunscreen with Aloe Vera SPF 30532 mL in 1 BOTTLE, PLASTICLOTION5321

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73563-011SUNSCREEN WITH ALOE VERA SPF 30 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [BODY ONE PRODUCTS, INC.]1Legacy NDC, 2 package rows20200205_9ab0b2d5-2c1c-4e6f-9ed7-10d3f1009e63.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73563-01173563-011-01, 73563-011-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octinoxate4Y5P7MUD51ACTIB
Octisalate4X49Y0596WACTIB
Oxybenzone95OOS7VE0YACTIB
Water059QF0KO0RIACT
Allantoin344S277G0ZIACT
Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked)Z135WT9208IACT
GULOSE, L-J96E9Q45N7IACT
Mineral OilT5L8T28FGPIACT
HEXAMETHYLDISILOXANED7M4659BPUIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
Stearic Acid4ELV7Z65APIACT
Aloe vera leafZY81Z83H0XIACT
PhenoxyethanolHIE492ZZ3TIACT
Glyceryl Stearate SEFCZ5MH785IIACT
Cetostearyl alcohol2DMT128M1SIACT
Polysorbate 60CAL22UVI4MIACT

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
d1ff5e22-6219-404c-9a2f-b9862dba0c369ab0b2d5-2c1c-4e6f-9ed7-10d3f1009e632020-01-31WarningsExact identifier
spl id: d1ff5e22-6219-404c-9a2f-b9862dba0c36
spl set id: 9ab0b2d5-2c1c-4e6f-9ed7-10d3f1009e63

Reported adverse events (FAERS/openFDA)#

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