SUN PLUS SKINCARE SPF 50 MINERAL BRONZING BODY BUTTER COCONUT- zinc oxide cream

Sun Plus Skincare SPF 50 Mineral Bronzing Body Butter Coconut by

Drug Labeling and Warnings

Sun Plus Skincare SPF 50 Mineral Bronzing Body Butter Coconut 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 22.0% 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. 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

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

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
Pacifca Beauty LLC
Portland, Oregon.

Sun Plus Skincare SPF 50 Mineral Bronzing Body Butter Coconut Label

INGREDIENTS AND APPEARANCE

SUN PLUS SKINCARE SPF 50 MINERAL BRONZING BODY BUTTER COCONUT 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61197-209
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MICA (UNII: V8A1AW0880)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM GLUCONATE (UNII: R6Q3791S76)
SHEA BUTTER (UNII: K49155WL9Y)
DOCOSANOL (UNII: 9G1OE216XY)
CAFFEINE (UNII: 3G6A5W338E)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
CETYL ALCOHOL (UNII: 936JST6JCN)
COCO GLUCOSIDE (UNII: ICS790225B)
COCONUT OIL (UNII: Q9L0O73W7L)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
COCOA BUTTER (UNII: 512OYT1CRR)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61197-209-00	147 mL in 1 TUBE; Type 0: Not a Combination Product	01/27/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	01/27/2023

Labeler - Pacifica Beauty, LLC (868275517)

Establishment
Name	Address	ID/FEI	Business Operations
Bell International Laboratories, Incorporated		967781555	manufacture(61197-209)