Sun Plus Skincare SPF 30 Sea and C Sheer Sunscreen

Sun Plus Skincare SPF 30 Sea and C Sheer Sunscreen by

Drug Labeling and Warnings

Sun Plus Skincare SPF 30 Sea and C Sheer Sunscreen 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]

SUN PLUS SKINCARE SPF 30 SEA AND C SHEER SUNSCREEN- octisalate, octocrylene, zinc oxide spray 
Pacifica Beauty, LLC

----------

Sun Plus Skincare SPF 30 Sea and C Sheer Sunscreen

Active ingredients Purpose

Octisalate 4.9% Sunscreen

Octocrylene 7.6% Sunscreen

Zinc Oxide 7.0% Sunscreen

Uses

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

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

Warnings

For external use only. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120ºF. For external use only. Do not use on damaged or broken skin. Stop use and 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.

Directions

Shake well. Do not spray on face. If using on face, spray onto hands & rub on skin. Apply liberally 15 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours. Children under 6 months: ask a doctor. 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.

Inactive ingredients:

Aqua, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Methyl Dihydroabietate, Acrylates Copolymer, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopherol (Vitamin E), Algae Extract, Ascophyllum Nodosum (Kelp) Extract, Laminaria Digitata (Algae) Extract, Jojoba Esters, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Citric Acid, Coco-Glucoside, Ethyl Ferulate, Glycerin, Glyceryl Stearate, Microcrystalline Cellulose, Sodium Gluconate, Xanthan Gum, Propanediol, Parfum (Natural).

Other information

Protect this product from excessive heat and direct sun.

Questions or comments?

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

Sun Plus Skincare SPF 30 Sea and C Sheer Sunscreen Label

Sun Plus Skincare SPF 30 Sea and C Sheer Sunscreen Label

SUN PLUS SKINCARE SPF 30 SEA AND C SHEER SUNSCREEN 
octisalate, octocrylene, zinc oxide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 61197-212
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
PROPANEDIOL (UNII: 5965N8W85T)  
ACRYLATES CROSSPOLYMER-4 (UNII: GEV2EL4D9G)  
FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
COCO GLUCOSIDE (UNII: ICS790225B)  
WATER (UNII: 059QF0KO0R)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ETHYL FERULATE (UNII: 5B8915UELW)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61197-212-00177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/09/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02002/09/202305/15/2024
Labeler - Pacifica Beauty, LLC (868275517)
Establishment
NameAddressID/FEIBusiness Operations
Bell International Laboratories, Incorporated967781555manufacture(61197-212)

Revised: 5/2024
 

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.