Label: MINERAL SUNSCREEN - WATER RESISTANT SPF-50- zinc oxide lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 71585-109-21 - Packager: SALT AND STONE
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 July 28, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
• Apply liberally 15 minutes before sun exposure
• 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 & other sun protection measures including:
• Limit time in the sun, especially from 10am - 2pm.
• Wear long-sleeve shirts, pants, hats, and sunglasses.
• Children under 6 months: Ask a doctor -
INACTIVE INGREDIENTS
Coco-Caprylate/Caprate, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Caprilic/capric triglyceride, Dimethicone, Octyl Palmitate, Butylene Glycol, PEG-30 Dipolyhydroxystearate, Cera Alba (Beeswax), Glycerol, Polyethylene, Rosa Canina (Rosehip) Seed Oil, Persea Gratissima (Avocado) Oil, Hyaluronic Acid, Ethylhexylglycerin, Phenoxyethanol, Glyceryl Oleate, Xanthan gum.
- OTHER INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MINERAL SUNSCREEN - WATER RESISTANT SPF-50
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71585-109 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 22.8 g in 100 mL Inactive Ingredients Ingredient Name Strength COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) ISOSTEARIC ACID (UNII: X33R8U0062) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYL PALMITATE (UNII: 2865993309) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO) YELLOW WAX (UNII: 2ZA36H0S2V) GLYCERIN (UNII: PDC6A3C0OX) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) ROSA CANINA SEED (UNII: 4503R1M9UT) AVOCADO OIL (UNII: 6VNO72PFC1) HYALURONIC ACID (UNII: S270N0TRQY) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERYL MONOOLEATE (UNII: C4YAD5F5G6) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71585-109-21 88 mL in 1 TUBE; Type 0: Not a Combination Product 07/28/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/28/2019 Labeler - SALT AND STONE (080683697)
