Label: DAILY FACE BROAD SPECTRUM- zinc oxide lotion
- NDC Code(s): 70533-001-50
- Packager: Harry's, Inc.
- Category: HUMAN OTC DRUG LABEL
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 April 4, 2016
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Use
- Warnings
-
Directions
For sunscreen use:
• apply liberally 15 minutes before sun exposure
• re-apply at least every two hours
• use a water-resistant sunscreen if swimming or sweating
• 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 this 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 10 a.m.
• wear long-sleeve shirts, pants, hats, and sunglasses.
-
Inactive ingredients
water/Aqua/Eau, Caprylic/Capric Triglyceride, Butylene Glycol, Dimethicone, Shea Butter Ethyl Esters, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Glycerin, Mentha Piperita (Peppermint) Oil , Eucalyptus Globulus Leaf Oil, Salix Alba (Willow) Bark Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Tocopheryl Acetate, Caffeine, Polyacrylamide, Streareth-100, C13-14 Isoparaffin, Xanthan Gum, Caprylyl Glycol, Polysorbate 20, Citric Acid, Potassium Sorbate, Laureth-7, Sodium Polyacrylate, Hexylene Glycol, Phenoxyethanol, Chlorphenesin
- Other information
- Questions or comments?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
DAILY FACE BROAD SPECTRUM
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70533-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 66 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIMETHICONE (UNII: 92RU3N3Y1O) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERIN (UNII: PDC6A3C0OX) PEPPERMINT OIL (UNII: AV092KU4JH) SALIX ALBA BARK (UNII: 205MXS71H7) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAFFEINE (UNII: 3G6A5W338E) STEARETH-100 (UNII: 4OH5W9UM87) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) XANTHAN GUM (UNII: TTV12P4NEE) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYSORBATE 20 (UNII: 7T1F30V5YH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) LAURETH-7 (UNII: Z95S6G8201) HEXYLENE GLYCOL (UNII: KEH0A3F75J) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70533-001-50 1 in 1 CARTON 04/03/2016 1 50 mL in 1 BOTTLE; 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 04/01/2016 Labeler - Harry's, Inc. (079239206)