FDA.reportPublic FDA data

Omega-Boost Sheer Mineral Sunscreen

Manufacturer
Trilogy Natural Products Limited
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:19:35

Label at a glance#

ProductOmega-Boost Sheer Mineral Sunscreen
Active ingredientZINC OXIDE
Label structure13 sections

Indications and uses

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

Dosage and administration

Apply generously 15 minutes before sun exposure” Reapply [bullet] after 80 minutes of swimming or sweating [bullet] immediately after towel drying [bullet] at least every 2 hours 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...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Zinc Oxide

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

  • For external use only.
  • Do not use on damaged or broken skin
  • When using this product [bullet] keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if [bullet] rash or irritation develops and lasts.
  • Keep out of reach of children, If product is swallowed, get medical help or contact poison control centre right away.
  • To ensure compatibility, we recommend patch testing before first use. In the unlikely event of a negative reaction, discontinue use and consult your medical practitioner.

Do not use

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply generously 15 minutes before sun exposure”
  • Reapply [bullet] after 80 minutes of swimming or sweating [bullet] immediately after towel drying [bullet] at least every 2 hours
  • 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Coco-caprylate/caprate, polyglyceryl-3 polyricinoleate, Isostearic acid, Castor oil, Caprilic/capric triglyceride, Coconut oil, Candellila wax, Hydrogenated castor oil, Tocopherol acetate, Rosehip oil, Avocado oil, Fragrance

Other Information

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun. Store below 30 degrees celcius.

Uses

OTC - PURPOSE SECTION

Helps prevent sunburn.

Trilogy SPF 60+ Omega-Boost Sheer Mineral Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 83105-2001-0

Secondary pacakaging

Secondary FlatSecondary Flat

NDC 83105-2001-1

75 mL / 2.5 fl oz

Principal Display Panel:

Front Outer PackageFront Outer Package

Inner Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 83105-2001-1

75 mL

Primary Container Label

Inner tube labelInner tube label

Sample Size Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83105-2001-2

5 mL

Sample sizeSample size

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83105-2001-0Omega-Boost Sheer Mineral Sunscreen1 in 1 BOXLOTION14
83105-2001-1Omega-Boost Sheer Mineral Sunscreen75 mL in 1 TUBELOTION754
83105-2001-2Omega-Boost Sheer Mineral Sunscreen5 mL in 1 PACKETLOTION54

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83105-200183105-2001-1, 83105-2001-0, 83105-2001-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
ISOSTEARIC ACIDX33R8U0062IACT
CASTOR OILD5340Y2I9GIACT
CANDELILLA WAXWL0328HX19IACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
ROSA MOSCHATA OILJ99W255AWFIACT
AVOCADO OIL6VNO72PFC1IACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
COCONUT OILQ9L0O73W7LIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT

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
Omega-Boost Sheer Mineral SunscreenMINERAL SUNSCREENTrilogy Natural Products Limited0405b7a6-6885-ed93-e063-6294a90a93862025-12-03WarningsExact identifier
ndc (package): 83105-2001-0
ndc (package): 83105-2001-2
ndc (package): 83105-2001-1
ndc (product): 83105-2001
ndc11 (package): 83105200101
ndc11 (package): 83105200100
ndc11 (package): 83105200102
spl id: 4515290c-6219-f9d9-e063-6294a90aacdc
spl set id: 0405b7a6-6885-ed93-e063-6294a90a9386

Reported adverse events (FAERS/openFDA)#

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