MILKY MINERAL SUN SERUM- titanium dioxide and zinc oxide lotion 
Synchronicity Spa, Inc. DBA Suntegrity

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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MILKY MINERAL SUN SERUM SPRAY

Drug Facts

Active IngredientPurpose
Titanium Dioxide (Non-Nano) 7.2%Sunscreen
Zinc Oxide (Non-Nano) 9.5%Sunscreen

Uses

Warnings

  • 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

Carthamus Tinctorius (Safflower) Seed Oil, Coconut Alkanes (And) Coco-Caprylate/Caprate, Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Pongamia Glabra (Karanja) Seed Oil , Olea Europaea (Olive) Fruit Oil, Argania Spinosa (Argan) Kernel Oil, Stearic Acid, Polyhydroxystearic Acid, Tocopheryl Acetate (Vitamin E), Carica Papaya (Papaya) Fruit Extract, Manifera Indica (Mango) Fruit Extract Alumina, Oryza Sativa (Rice) Bran Extract, Bisabolol, Helianthus Annuus (Sunflower) Extract, 1Squalane, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol,


1
From Sugarcane

Uses

Distributed By: Suntegrity® Skincare Las Vegas, NV 89128

PRINCIPAL DISPLAY PANEL - 100 ML Bottle Label

sun
tegrity®

MILKY MINERAL

SUN SERUM SPRAY

FOR FACE & BODY

BROAD SPECTRUM SPF 50

SPF
50

WITH ARGAN & KARANJA OIL

MANGO PAPAYA SCENT

Light, Non-Sticky Texture

Vegan | Reef Friendly

3.4 FL OZ (100 ML)

PRINCIPAL DISPLAY PANEL - 100 ML Bottle Label
MILKY MINERAL SUN SERUM 
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69949-400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE72 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE95 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SAFFLOWER OIL (UNII: 65UEH262IS)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
KARUM SEED OIL (UNII: 62160PU6FJ)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
ARGAN OIL (UNII: 4V59G5UW9X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PAPAYA (UNII: KU94FIY6JB)  
MANGO (UNII: I629I3NR86)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
RICE BRAN (UNII: R60QEP13IC)  
LEVOMENOL (UNII: 24WE03BX2T)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
SQUALANE (UNII: GW89575KF9)  
ROSEMARY (UNII: IJ67X351P9)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69949-400-01100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2022
Labeler - Synchronicity Spa, Inc. DBA Suntegrity (079164130)

Revised: 6/2022
Document Id: d46b486a-6ad5-427e-9ee3-7474977b0901
Set id: 53834c89-b3b4-4e21-b9f6-19f95e78ba83
Version: 1
Effective Time: 20220624
 
Synchronicity Spa, Inc. DBA Suntegrity