CAUDALIE DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion 
Caudalie USA, Inc.

----------

CAUDALIE Daily Mineral Sunscreen Broad Spectrum SPF 50 Lotion

Drug Facts

Active ingredient Purpose

Zinc Oxide 21.1% ...... Sunscreen

Uses

Warnings

For external use only.

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

Stop use and ask a doctor if • rash occurs.

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

30 mL Outer Label_Page_130 mL Outer Label_Page_230 mL Inner Label

50 mL Pack

50 mL Outer Label50 mL Inner Label

Co-pack

Copack Label

CAUDALIE DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76296-060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13.1875 g  in 62.5 g
Inactive Ingredients
Ingredient NameStrength
PROPANEDIOL (UNII: 5965N8W85T)  
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
WATER (UNII: 059QF0KO0R)  
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)  
BENTONITE (UNII: A3N5ZCN45C)  
ETHYL FERULATE (UNII: 5B8915UELW)  
COCO GLUCOSIDE (UNII: ICS790225B)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SUCROSE STEARATE (UNII: 274KW0O50M)  
SQUALENE (UNII: 7QWM220FJH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76296-060-301 in 1 CARTON05/20/2024
137.5 g in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:76296-060-501 in 1 CARTON05/20/2024
262.5 g in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:76296-060-391 in 1 CARTON05/20/2024
337.5 g in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/20/2024
Labeler - Caudalie USA, Inc. (100064349)

Revised: 4/2024
Document Id: 150e3bf3-7b06-e611-e063-6294a90a0932
Set id: 150e3bf3-7b05-e611-e063-6294a90a0932
Version: 1
Effective Time: 20240401
 
Caudalie USA, Inc.