NDC | 49358-559-01 |
Set ID | 4f0bf232-645a-4f69-b386-3a138a5c9964 |
Category | HUMAN OTC DRUG LABEL |
Packager | MDSolarSciences |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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
-
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
- 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
-
Inactive Ingredients
Dimethicone, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Glyceryl Isostearate, Polyhydroxystearic Acid, Dimethicone/ Vinyl Dimethicone Crosspolymer, Silica, Butyl Octyl Salicylate Polysilicone-15, Tetrahexyldecyl Ascorbate, Camellia Sinensis (Green Tea) Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Punica Granatum (Pomegranate) Extract, Iron oxide, PEG/PPG-18/18 Dimethicone, Triethoxy-caprylylsilane, Ubiquinone, Tocopheryl Acetate, Squalane
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 71 g Tube Carton
MDSolarSciences™
40
KidCrèmeMINERAL 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-Freesun care
Net Wt. 71g -2.54Oz
-
INGREDIENTS AND APPEARANCE
KIDCREME MINERAL BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNCREEN
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49358-559 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 2.7 g in 35 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 1.3 g in 35 g Inactive Ingredients Ingredient Name Strength Dimethicone (UNII: 92RU3N3Y1O) DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYSILICONE-15 (UNII: F8DRP5BB29) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CRANBERRY (UNII: 0MVO31Q3QS) POMEGRANATE JUICE (UNII: 99S671U9KB) FERRIC OXIDE RED (UNII: 1K09F3G675) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) UBIDECARENONE (UNII: EJ27X76M46) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SQUALANE (UNII: GW89575KF9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49358-559-01 1 in 1 CARTON 06/16/2017 1 48 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)