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

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]

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.

INDICATIONS & USAGE

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

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61197-212
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
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61197-212-00	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/09/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	02/09/2023

Labeler - Pacifica Beauty, LLC (868275517)

Establishment
Name	Address	ID/FEI	Business Operations
Bell International Laboratories, Incorporated		967781555	manufacture(61197-212)