OMEGA-BOOST SHEER MINERAL SUNSCREEN- mineral sunscreen lotion

Omega-Boost Sheer Mineral Sunscreen by

Drug Labeling and Warnings

Omega-Boost Sheer Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Trilogy Natural Products Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active Ingredient: Zinc Oxide

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

Warnings

• 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

Do not use on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

KEEP OUT OF REACH OF CHILDREN

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

Directions

• 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

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

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

Uses

Helps prevent sunburn.

Trilogy SPF 60+ Omega-Boost Sheer Mineral Sunscreen

NDC: 83105-2001-0

Secondary pacakaging

NDC: 83105-2001-1

75 mL / 2.5 fl oz

Principal Display Panel:

Inner Container Label

NDC: 83105-2001-1

75 mL

Primary Container Label

Sample Size Package

83105-2001-2

5 mL

INGREDIENTS AND APPEARANCE

OMEGA-BOOST SHEER MINERAL SUNSCREEN 
mineral sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83105-2001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	229.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARIC ACID (UNII: X33R8U0062)
CASTOR OIL (UNII: D5340Y2I9G)
CANDELILLA WAX (UNII: WL0328HX19)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ROSA MOSCHATA OIL (UNII: J99W255AWF)
AVOCADO OIL (UNII: 6VNO72PFC1)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
COCONUT OIL (UNII: Q9L0O73W7L)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83105-2001-0	1 in 1 BOX	11/01/2023
1	NDC: 83105-2001-1	75 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 83105-2001-2	5 mL in 1 PACKET; Type 0: Not a Combination Product	11/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/01/2023

Labeler - Trilogy Natural Products Limited (591496997)