SEA CLEARLY HYDRATING FACIAL SPF 35 KINETIN- octocrylene, octisalate,homosalat, avobenzone cream 
Allure Labs

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Drug Facts

Active ingredient,

Octocrylene – 10 %

Octisalate – 5%

Homosalate – 5%

Avobenzone – 2.5 %

Purpose: Sunscreen

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

For external use only.

Do not use on damaged or broken skin.

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

Stop use and ask doctor if skin rash occurs.

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

Directions.

Apply generously and evenly 15 minutes before sun exposure.

Reapply: after 40 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 information.

Protect this product from excessive heat and direct sun.

Inactive ingredient:

Isododecane, Polymethylsilsesquioxane, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Dimethicone Crosspolymer, Dimethicone,Camellia Oleifera (Seed) Oil,Prunus Armeniaca (Apricot) Kernel Oil, Carthamus Tinctorius ( Safflower) Seed Oil, Aloe Barbandensis Leaf Extract, Kinetin, Squalane,Tocopherol, Tocopheryl Acetate.

Sea Clearly Hydrating Facial SPF 35

SEA CLEARLY HYDRATING FACIAL SPF 35 KINETIN 
octocrylene, octisalate,homosalat, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4237
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT)  
KINETIN (UNII: P39Y9652YJ)  
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CAMELLIA OIL (UNII: T1PE06G0VE)  
APRICOT KERNEL OIL (UNII: 54JB35T06A)  
ISODODECANE (UNII: A8289P68Y2)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
SQUALANE (UNII: GW89575KF9)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4237-150 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/05/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/05/2023
Labeler - Allure Labs (926831603)
Registrant - Allure Labs (926831603)
Establishment
NameAddressID/FEIBusiness Operations
Allure Labs926831603manufacture(62742-4237)

Revised: 12/2023
Document Id: 0bc829ff-34a1-03e9-e063-6294a90a10ae
Set id: 0bc829ff-34a0-03e9-e063-6294a90a10ae
Version: 1
Effective Time: 20231205
 
Allure Labs