Label: MINERAL KIDSTICK SPF 40 MINERAL BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNCREEN- titanium dioxide and zinc oxide stick
- NDC Code(s): 49358-576-01
- Packager: MDSolarSciences
- 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 September 11, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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Directions
- Apply liberally 15 minutes before sun exposure
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Reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- 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 the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10a.m.-2p.m.
- Wear long-sleeved shirts, pants, hats and sunglasses
- Other Information
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Inactive Ingredients
Polyethylene, Dimethicone, Butyloctyl Salicylate, Petrolatum, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylic/ Capric Triglyceride, Methyl Dihydroabietate, Acrylates/Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Octyldodecanol, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopherol (Vitamin E), Behenyl Olivate, Aluminum Hydroxide, Stearic Acid, Sorbitan Sesquioleate, Glyceryl Isostearate, Polyhydroxystearic Acid, Citric Acid, Benzylidene Dimethoxydimethylindanone
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 17 G Tube Carton
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INGREDIENTS AND APPEARANCE
MINERAL KIDSTICK SPF 40 MINERAL BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNCREEN
titanium dioxide and zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49358-576 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 81 mg in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 60 mg in 1 g Inactive Ingredients Ingredient Name Strength HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) PETROLATUM (UNII: 4T6H12BN9U) SHEA BUTTER (UNII: K49155WL9Y) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) 2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M) OCTYLDODECANOL (UNII: 461N1O614Y) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) TOCOPHEROL (UNII: R0ZB2556P8) BEHENYL OLIVATE (UNII: NGS1GGK4GW) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49358-576-01 1 in 1 CARTON 07/01/2023 1 17 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 07/01/2023 Labeler - MDSolarSciences (013647301)
