SEA AND C SHEER FACE SERUM- avobenzone, homosalate, octisalate, octocrylene liquid 
Pacifica Beauty, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sea and C Sheer Face Serum SPF 55

Active ingredients

Avobenzone 2.9% Sunscreen

Homosalate 9.8% Sunscreen

Octisalate 4.9% Sunscreen

Octocrylene 9.5% Sunscreen

Uses

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

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

Warnings

For external use only. Do not use on damaged or broken skin. Stop use & ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Kep out of reach of children.

Directions

Shake well. Apply liberally 15 minutes before sun exposure. Use water resistant sunscreen if swimming or sweating. Reapply after swimming or sweating. Reapply at least every 2 hours. Sun protection measures. Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher & other sun protection measures including: - limit time in the sun, especially from 10 a.m. - 2 p.m. - wear long-sleeve shirts, pants, hats & sunglasses. Children under 6 months: ask a doctor.

Inactive ingredients:

Aqua, Butyloctyl Salicylate, Coconut Alkanes, Calcium Sodium Borosilicate, Cetearyl Alcohol, Parfum (Natural), Propanediol, Ascorbate (Vitamin C), Tocopherol (Vitamin E), Ascophyllum Nodosum (Kelp) Extract, Algae Extract, Withania Somnifera (Ashwagandha) Root Extract, Aloe Barbadensis Leaf Juice, Caffeine, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Coco Caprylate/ Caprate, Coco-Glucoside, Ethyl Ferulate, Fructose, Glycerin, Glyceryl Stearate, Lauroyl Lysine, Microcrystalline Cellulose, Sodium Gluconate, Sodium Stearoyl Glutamate, Xanthan Gum.

Other information

Protect this product from excessive heat & direct sun.

Questions or comments?

Call toll free 1-888-322-2466
Pacifica Beauty LLC Portland, Oregon

Sea and C Sheer Face Serum SPF 55 Label

Sea and C Sheer Face Serum SPF 55 Label

SEA AND C SHEER FACE SERUM 
avobenzone, homosalate, octisalate, octocrylene liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61197-216
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9.8 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.9 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
GLYCERIN (UNII: PDC6A3C0OX)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
FRUCTOSE (UNII: 6YSS42VSEV)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
LAUROYL LYSINE (UNII: 113171Q70B)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
COCO GLUCOSIDE (UNII: ICS790225B)  
ETHYL FERULATE (UNII: 5B8915UELW)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
CAFFEINE (UNII: 3G6A5W338E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PROPANEDIOL (UNII: 5965N8W85T)  
CALCIUM ASCORBATE (UNII: 183E4W213W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61197-216-0050 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/03/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02002/03/2023
Labeler - Pacifica Beauty, LLC (868275517)
Establishment
NameAddressID/FEIBusiness Operations
Bell International Laboratories, Incorporated967781555manufacture(61197-216)

Revised: 2/2023
Document Id: f3d3b228-c856-a9b9-e053-2995a90a13f4
Set id: f3d3b228-c855-a9b9-e053-2995a90a13f4
Version: 1
Effective Time: 20230203
 
Pacifica Beauty, LLC