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

Sea and C Sheer Face Serum by

Drug Labeling and Warnings

Sea and C Sheer Face Serum by is a Otc medication manufactured, distributed, or labeled by Pacifica Beauty, LLC, Bell International Laboratories, Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

INDICATIONS & USAGE

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.

KEEP OUT OF REACH OF CHILDREN

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

INGREDIENTS AND APPEARANCE

SEA AND C SHEER FACE SERUM 
avobenzone, homosalate, octisalate, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61197-216
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.9 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9.8 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61197-216-00	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/03/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	02/03/2023

Labeler - Pacifica Beauty, LLC (868275517)

Establishment
Name	Address	ID/FEI	Business Operations
Bell International Laboratories, Incorporated		967781555	manufacture(61197-216)