Sun Plus Skincare SPF 30 Mineral Bronzing Sunscreen Coconut Glow

Sun Plus Skincare SPF 30 Mineral Bronzing Sunscreen Coconut Glow by

Drug Labeling and Warnings

Sun Plus Skincare SPF 30 Mineral Bronzing Sunscreen Coconut Glow 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 MINERAL BRONZING SUNSCREEN COCONUT GLOW- zinc oxide liquid 
Pacifica Beauty, LLC

----------

Sun Plus Skincare SPF 30 Mineral Bronzing Sunscreen Coconut Glow

Active Ingredients Purpose

Zinc Oxide 14.5% 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. Sto 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 onface. If using on face, spray onto hands and run 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 and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher andother sun protection measures including - limit time in the sun, especially from 10 a.m. - 2 p.m. - wear long-sleeve shirts, pants, hats and sunglasses.

Inactive ingredients:

Bentonite, Bisabolol, Butyloctyl SAlicylate, Caffeine, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Coco-Glucoside, Ethyl Macadamiate, Glycerin, Iron Oxides, Jojoba Esters, Lactococcus Ferment Lysate, Methyl Dihydroabietate, Microcrystalline Cellulose, Octyldodecyl Oleate, Parfum (natural), Propanediol, Shea Butter Ethyl Esters, Tocopherol (Vitamin E), Water.

Other information

Protect this product from excessive heat and direct sun. Can stain clothing. Keep away from clothes.

Questions or comments?

Call toll free 1-888-322-2466

Pacifica Beauty LLC Portland, Oregon

Sun Plus Skincare SPF 30 Mineral Bronzing Sunscreen Coconut Glow Label

Sun Plus Skincare SPF 30 Mineral Bronzing Sunscreen Coconut Glow Label

SUN PLUS SKINCARE SPF 30 MINERAL BRONZING SUNSCREEN COCONUT GLOW 
zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 61197-208
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
BENTONITE (UNII: A3N5ZCN45C)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)  
PROPANEDIOL (UNII: 5965N8W85T)  
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
TOCOPHEROL (UNII: R0ZB2556P8)  
WATER (UNII: 059QF0KO0R)  
COCO GLUCOSIDE (UNII: ICS790225B)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
CAFFEINE (UNII: 3G6A5W338E)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61197-208-00177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/25/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/25/202305/15/2024
Labeler - Pacifica Beauty, LLC (868275517)
Establishment
NameAddressID/FEIBusiness Operations
Bell International Laboratories, Incorporated967781555manufacture(61197-208)

Revised: 5/2024
 

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