CAUDALIE DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion

CAUDALIE Daily Mineral Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

CAUDALIE Daily Mineral Sunscreen Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by Caudalie USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

PURPOSE

Active ingredient Purpose

Zinc Oxide 21.1% ...... 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.

DO NOT USE

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply generously and evenly 15 minutes before sun exposure.

Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regulalry 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-sleeved shirts, pants, hats, and singlasses.

Children under 6 months of age: Ask a doctor.

Other information

Protect the product in this contaner from excessive heat and direct sun.

Inactive ingredients

Aqua/Water/Eau, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Calcium Sodium Borosilicate, Erythritol, Lauryl Laurate, Propanediol, Carthamus Tinctorius Oleosomes, Bentonite, Niacinamide, Palmitoyl Grapevine Shoot Extract, Cetearyl Alcohol, Caprylyl Glycol, Ethyl Ferulate, Sucrose Polystearate, Helianthus Annuus (Sunflower) Seed Oil,Sucrose Stearate, Coco-Glucoside, Bisabolol, Citric Acid, Caramel, Polyhydroxystearic Acid, Pongamia Pinnata Seed Extract, Sodium Gluconate, Caprylhydroxamic Acid, Glycerin, Tocopherol, Microcrystallnine Cellulose, Beta-Sitosterol, Gluconolactone, Squalene, Xanthan Gum, Aloe Barbadensis Leaf Juice Powder, Sodium Benzoate.

Questions?

+1-866-826-1615

30 mL Pack

50 mL Pack

Co-pack

INGREDIENTS AND APPEARANCE

CAUDALIE DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76296-060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	13.1875 g  in 62.5 g

Inactive Ingredients
Ingredient Name	Strength
PROPANEDIOL (UNII: 5965N8W85T)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
LEVOMENOL (UNII: 24WE03BX2T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CARAMEL (UNII: T9D99G2B1R)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
XANTHAN GUM (UNII: TTV12P4NEE)
BOROSILICATE GLASS (UNII: BOJ6T9AR90)
SODIUM GLUCONATE (UNII: R6Q3791S76)
TOCOPHEROL (UNII: R0ZB2556P8)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ERYTHRITOL (UNII: RA96B954X6)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
LAURYL LAURATE (UNII: GPW77G0937)
WATER (UNII: 059QF0KO0R)
BENTONITE (UNII: A3N5ZCN45C)
ETHYL FERULATE (UNII: 5B8915UELW)
COCO GLUCOSIDE (UNII: ICS790225B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SUCROSE STEARATE (UNII: 274KW0O50M)
SQUALENE (UNII: 7QWM220FJH)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76296-060-30	1 in 1 CARTON	05/20/2024
1		37.5 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 76296-060-50	1 in 1 CARTON	05/20/2024
2		62.5 g in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 76296-060-39	1 in 1 CARTON	05/20/2024
3		37.5 g in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/20/2024

Labeler - Caudalie USA, Inc. (100064349)