CHANTECAILLE SEASCREEN 30 MINERAL BROAD-SPECTRUM SUNSCREEN MIST SPF 30- zinc oxide aerosol, spray

Chantecaille SeaScreen 30 Mineral Broad-Spectrum Sunscreen Mist by

Drug Labeling and Warnings

Chantecaille SeaScreen 30 Mineral Broad-Spectrum Sunscreen Mist by is a Otc medication manufactured, distributed, or labeled by Chantecaille Beaute Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide - 15.2%

PURPOSE

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.

Warnings

For external use only.

Contents under pressure. Do not puncture or incinerate.

Do note store at temperatures above 120 F.

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.

Directions

Hold container 4 to 6 inches from the skin to apply

Spay liberally and spread evenly by hand 15 minutes before sun exposure

Do not spray directly into face. Spray on hands then apply to face

Do not apply in windy conditions

Use in a well-ventilated areas

Reapply:

-After 80 minutes of swimming or sweating

-Immediately after towel drying

-At least every 2 hours

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other protection measures including:

-Limit time in the sun, especially from 10 a.m. – 2 p.m.

-Wear long sleeves shirts, pants, hats, and sunglasses.

Children under 6 months: ask a doctor.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact Poison Control Center right away.

Inactive Ingredients

Citrus Aurantium Dulcis (Orange) Fruit Water, Water, Simmondsia Chinensis (Jojoba) Seed Oil, Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil, Methyl Dihydroabietate, Glycerin, Cetearyl Alcohol, Coco-Glucoside, Bentonite, Shea Butter Ethyl Esters, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Rubus Idaeus (Raspberry) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Portulaca Oleracea Extract, Withania Somnifera Root Extract, Camellia Sinensis Leaf Extract, Fructose, Bisabolol, Ethyl Ferulate, Microcrystalline Cellulose, Cellulose Gum, Sodium Stearoyl Glutamate, Sodium Gluconate, Citric Acid, Caprylhydroxamic Acid, Caprylyl Glycol, Capryloyl Glycerin/Sebacic Acid Copolymer, Citrus Nobilis (Mandarin Orange) Peel Oil

Other Information

Protect this product from excessive heat and direct sun

Questions

To report a serious adverse event contact Chantecaille Beaute, Inc. 584 Broadway No. 1111 New York NY 10012

Package Label

INGREDIENTS AND APPEARANCE

CHANTECAILLE SEASCREEN 30 MINERAL BROAD-SPECTRUM SUNSCREEN MIST  SPF 30
zinc oxide aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42893-328
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENTONITE (UNII: A3N5ZCN45C)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COCONUT OIL (UNII: Q9L0O73W7L)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
LEVOMENOL (UNII: 24WE03BX2T)
RASPBERRY SEED OIL (UNII: 9S8867952A)
PURSLANE (UNII: M6S840WXG5)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
ORANGE (UNII: 5EVU04N5QU)
JOJOBA OIL (UNII: 724GKU717M)
SODIUM GLUCONATE (UNII: R6Q3791S76)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ROSEMARY (UNII: IJ67X351P9)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
FRUCTOSE (UNII: 6YSS42VSEV)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
COCO GLUCOSIDE (UNII: ICS790225B)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ETHYL FERULATE (UNII: 5B8915UELW)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
WATER (UNII: 059QF0KO0R)
MANDARIN OIL (UNII: NJO720F72R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42893-328-13	177 mL in 1 CAN; Type 0: Not a Combination Product	11/22/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/22/2021

Labeler - Chantecaille Beaute Inc (095270166)