Label: KIDSTICK MINERAL BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN- titanium dioxide and zinc oxide stick
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Contains inactivated NDC Code(s)
NDC Code(s): 49358-560-01 - 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 October 25, 2018
If you are a consumer or patient please visit this version.
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- 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
- Reapply:
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- After 80 minutes of swimming or sweating
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- Immediately after towel drying
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- At least every 2 hours
- Children under 6 months: Ask a doctor
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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:
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- Limit time in the sun, especially from 10a.m.-2p.m.
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- Wear long-sleeved shirts, pants, hats and sunglasses
- Other Information
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Inactive Ingredients
Polyethylene, Dimethicone, Butyrospermum Parkii (Shea) Butter, Petrolatum, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Undecylcrylene Dimethicone, Neopentyl Glycol Diheptanoate, Acrylates/Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Behenyl Olivate, Aluminum Hydroxide, Stearic Acid, Glyceryl Isostearate, Beeswax, Polyhydroxystearic Acid, Cetyl PEG/PPG-10/1 Dimethicone, BHT, Benzylidene Dimethoxydimethylindanone, Tetrahexyldecyl Ascorbate
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 12 g Tube Carton
MDSolarSciences™
40
KidStickMINERAL SUNSCREEN
BROAD SPECTRUM
SPF 40
UVA-UVB SUNSCREENGentle enough for sensitive skin
Safe for children
6 months and olderDermatologist developed,
approved & recommendedWater resistant (80 minutes)
Non - Comedogenic - Won't clog pores
Oil - Free - Fragrance - Free
sun care
Net Wt. 12g-0.4Oz
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INGREDIENTS AND APPEARANCE
KIDSTICK MINERAL BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN
titanium dioxide and zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49358-560 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.96 g in 12 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.792 g in 12 g Inactive Ingredients Ingredient Name Strength HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) Dimethicone (UNII: 92RU3N3Y1O) SHEA BUTTER (UNII: K49155WL9Y) PETROLATUM (UNII: 4T6H12BN9U) BUTYLOCTYL OLEATE (UNII: 2830Y2FNR6) SALICYLIC ACID (UNII: O414PZ4LPZ) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) BEHENYL OLIVATE (UNII: NGS1GGK4GW) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) YELLOW WAX (UNII: 2ZA36H0S2V) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49358-560-01 1 in 1 CARTON 06/16/2017 1 35 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 06/16/2017 Labeler - MDSolarSciences (013647301)