SEA CLEARLY TRANSLUCENT GEL SUNSCREEN BS SPF 50- homosalate, octocrylene, octisalate, avobenzone gel

Sea Clearly Translucent Gel Sunscreen BS SPF 50 by

Drug Labeling and Warnings

Sea Clearly Translucent Gel Sunscreen BS SPF 50 by is a Otc medication manufactured, distributed, or labeled by Allure Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient,

Homosalate – 10 %

Octocrylene – 10 %

Octisalate - 5%

Avobenzone – 3%

PURPOSE

Purpose.

Sunscreen

INDICATIONS & USAGE

Uses. Helps prevent sunburn.

If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS

Warnings- For external use only.

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

When using this product keep out of eye.Rinse with water to remove.

STOP USE

Stop use and ask doctor if skin rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children, If product is swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION

Directions.

Apply generously and evenly 15 minutes before sun exposure.

Reapply: after 80 minutes of swimming or sweating.

Immediately after towel drying. At least every 2 hours. Sun Protection Measures: Spending time the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use of 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. Children under 6 months of age: Ask a doctor.

OTHER SAFETY INFORMATION

Other information.

Protect this product from excessive heat an direct sun.

May stain some fabrics.

INACTIVE INGREDIENT

Inactive ingredient:

Caprylic/Capric Triglyceride, Stearalkonium Hectorite, Polymethylsilsesquioxane, Euphorbia Cerifera (Candelilla) Wax, Copernicia Prunifera (Carnauba) Wax, Bentonite, Propylene Carbonate, Dimethicone, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate ( Vitamin E), Ferulic Acid.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SEA CLEARLY TRANSLUCENT GEL SUNSCREEN BS SPF 50 
homosalate, octocrylene, octisalate, avobenzone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4235
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT)
CANDELILLA WAX (UNII: WL0328HX19)
BENTONITE (UNII: A3N5ZCN45C)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
FERULIC ACID (UNII: AVM951ZWST)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4235-1	100 g in 1 TUBE; Type 0: Not a Combination Product	12/04/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/04/2023

Labeler - Allure Labs (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4235)