- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
-
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
- Diretions for full protection, apply liberally (2mg/cm2) to all exposed skin 15 minutes before sun exposure then rub it in to reduce whitening effect.
Reapply:
- After 40 minutes of swimming or sweating • Immediately after towel drying. • At least every two hours.
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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10am-2pm
- Wear long-sleeved shirts, pants, hats, and sunglasses
- For children under six months of age ask a doctor.
- Ingredients
- Other information:
- PRINCIPAL DISPLAY PANEL - 118 ml Tube
-
INGREDIENTS AND APPEARANCE
MADE OF BROAD SPECTRUM SPF 30 NON-NANO ZINC OXIDE SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71439-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 g in 100 mL Inactive Ingredients Ingredient Name Strength VANILLA PLANIFOLIA OIL (UNII: 0A3F415158) ARGAN OIL (UNII: 4V59G5UW9X) RASPBERRY SEED OIL (UNII: 9S8867952A) TOCOPHEROL (UNII: R0ZB2556P8) COCOA BUTTER (UNII: 512OYT1CRR) COCONUT OIL (UNII: Q9L0O73W7L) SUNFLOWER OIL (UNII: 3W1JG795YI) YELLOW WAX (UNII: 2ZA36H0S2V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71439-050-16 1 in 1 CARTON 09/05/2017 1 118 mL 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 not final part352 09/05/2017 Labeler - MADEOF, LLC (080635957)