SUN PLUS SKINCARE SPF 30 MINERAL BRONZING FACE SHADE COCONUT GLOW- zinc oxide lotion

Sun Plus Skincare SPF 30 Mineral Bronzing Face Shade Coconut Glow by

Drug Labeling and Warnings

Sun Plus Skincare SPF 30 Mineral Bronzing Face Shade 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]

Active Ingredients Purpose

Zinc Oxide 20% 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 and 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. 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 Ouf Of Reach Of Children

Keep Ouf Of Reach Of Children.

Directions for Use

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 and other 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

Aloe Barbadensis Leaf, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea Butter), Caffeine, Caprylhydroxamic Acid , Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Glycerin, Iron Oxides, Lactococcus Ferment Lysate, Methyl Dihydroabietate, Mica, Microcrystalline Cellulose, Octyldodecyl Oleate, Parfum (Natural), Polyhydroxystearic Acid, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Titanium Dioxide, Tocopherol, 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUN PLUS SKINCARE SPF 30 MINERAL BRONZING FACE SHADE COCONUT GLOW 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61197-610
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM GLUCONATE (UNII: R6Q3791S76)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAFFEINE (UNII: 3G6A5W338E)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COCO GLUCOSIDE (UNII: ICS790225B)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
COCOA BUTTER (UNII: 512OYT1CRR)
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
TOCOPHEROL (UNII: R0ZB2556P8)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DOCOSANOL (UNII: 9G1OE216XY)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
COCONUT OIL (UNII: Q9L0O73W7L)
MICA (UNII: V8A1AW0880)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61197-610-00	50 mL in 1 TUBE; Type 0: Not a Combination Product	01/20/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	01/20/2023

Labeler - Pacifica Beauty, LLC (868275517)

Establishment
Name	Address	ID/FEI	Business Operations
Bell International Laboratories, Incorporated		967781555	manufacture(61197-610)