FDA.reportPublic FDA data

Be Sweet SPF 15 Tinted

Manufacturer
Bona Fide Beauty Lab PS LLC
Effective date
2018-02-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:47

Label at a glance#

ProductBe Sweet SPF 15 Tinted Clear Skies
Active ingredientAVOBENZONE, OCTINOXATE
Label structure8 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 of age, ask a doctor prior to use

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone - 3.0%
Octinoxate - 7.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Warnings

WARNINGS 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.

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 for sunscreen use:

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 of age, ask a doctor prior to use

Other Information

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients:

INDICATIONS & USAGE SECTION

Ricinus Communis (Castor) Seed Oil, Lanolin Oil, Octyldodecanol, Propylene Glycol Ricinoleate, Euphorbia Cerifera (Candelilla) Wax, Isopropyl Lanolate, Lanolin, C12-15 Alkyl Benzoate, Oleyl Alcohol, Polybutene, Ozokerite, Paraffin, Copernicia Cerifera (Carnauba) Wax, Ethylhexyl  Palmitate, Propylene Glycol, Flavor (Aroma), Disteardimonium Hectorite, Ascorbyl Palmitate, Tribehenin, Vitis Vinifera (Grape) Seed Oil, Retinyl Palmitate, Carthamus Tinctorius (Safflower) Seed Oil, Tocopherol, Glycine Soja (Soybean) Oil, Sorbitan Isostearate, Stevioside, Aloe Barbadensis Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, BHT, Palmitoyl Tripeptide-1, Hibiscus Sabdariffa Flower Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Camellia Sinensis Leaf Extract. MAY CONTAIN (+/-): Titanium Dioxide (CI 77891), Mica (CI 77019), Iron Oxides (CI
77491, 77499), Red 7 Lake (CI 15850), Yellow 5 Lake (CI 19140), Yellow 6 Lake (CI 15985), Red 22 Lake (CI 45380), Red 28 Lake (CI 45410).

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner Package3Inner Package3Clear SkiesClear Skies

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72112-003-012021-01-29C16284748780-1ba0f9c33-1904-a910-e053-dadaa90a0b85Be Sweet SPF 15 Tinted Lip Balm Clear Skies

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72112-003-01Be Sweet SPF 15 TintedClear Skies2.7 g in 1 CONTAINERGEL2.71
72112-003-01Be Sweet SPF 15 TintedClear Skies1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72112-003BE SWEET SPF 15 TINTED CLEAR SKIES (AVOBENZONE, OCTINOXATE) GEL [BONA FIDE BEAUTY LAB PS LLC]1Legacy NDC, 2 package rows20180301_c13ef641-ea20-4854-b8cb-a0e259a3aee9.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72112-00372112-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
CASTOR OILD5340Y2I9GIACT
LANOLIN OILOVV5IIJ58FIACT
OCTYLDODECANOL461N1O614YIACT
PROPYLENE GLYCOL RICINOLEATEWD6G36K42UIACT
CANDELILLA WAXWL0328HX19IACT
LANOLIN7EV65EAW6HIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
OLEYL ALCOHOL172F2WN8DVIACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
CERESINQ1LS2UJO3AIACT
PARAFFINI9O0E3H2ZEIACT
CARNAUBA WAXR12CBM0EIZIACT
ETHYLHEXYL PALMITATE2865993309IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYL SALICYLATELAV5U5022YIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ASCORBYL PALMITATEQN83US2B0NIACT
TRIBEHENIN8OC9U7TQZ0IACT
GRAPE SEED OIL930MLC8XGGIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
SAFFLOWER OIL65UEH262ISIACT
TOCOPHEROLR0ZB2556P8IACT
SOYBEAN OIL241ATL177AIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
STEVIOSIDE0YON5MXJ9PIACT
ALOE VERA LEAFZY81Z83H0XIACT
SUNFLOWER OIL3W1JG795YIIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
HIBISCUS SABDARIFFA FLOWER45TGG6IU6MIACT
LOWBUSH BLUEBERRYG90PX41VP0IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB

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
6557638a-9af5-94e2-e053-2991aa0a06cdc13ef641-ea20-4854-b8cb-a0e259a3aee92018-02-16WarningsExact identifier
spl id: 6557638a-9af5-94e2-e053-2991aa0a06cd
spl set id: c13ef641-ea20-4854-b8cb-a0e259a3aee9

Reported adverse events (FAERS/openFDA)#

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