Label: MILKY MINERAL SUN SERUM- titanium dioxide and zinc oxide lotion
- NDC Code(s): 69949-400-01
- Packager: Synchronicity Spa, Inc. DBA Suntegrity
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 24, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
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Directions
- Shake well. Do not spray on face. If using on face, spray onto hands and rub on skin.
- Apply liberally 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
- Children under 6 months: Ask a doctor
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF 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 & sunglasses
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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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 100 ML Bottle Label
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INGREDIENTS AND APPEARANCE
MILKY MINERAL SUN SERUM
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69949-400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 72 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 95 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:69949-400-01 100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 04/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2022 Labeler - Synchronicity Spa, Inc. DBA Suntegrity (079164130)
