Label: KIINSUN SUNSCREEN BROAD SPECTRUM SPF50- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 72431-001-01 - Packager: Grupo Pogami, S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 June 3, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Uses
- Warnings
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Directions
- for sunscreen use
- apply generously 15 minutes before sun exposure
- children under 6 months of age: Ask a doctor
- reapply:
- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m.- 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses.
- Other information
- Inactive ingredients
- Questions?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
KIINSUN SUNSCREEN BROAD SPECTRUM SPF50
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72431-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 65 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 60 mg in 1 g Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) CETYL ALCOHOL (UNII: 936JST6JCN) CHLORPHENESIN (UNII: I670DAL4SZ) WATER (UNII: 059QF0KO0R) GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERIN (UNII: PDC6A3C0OX) SORBIC ACID (UNII: X045WJ989B) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72431-001-01 165 g in 1 TUBE; Type 0: Not a Combination Product 01/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/02/2020 Labeler - Grupo Pogami, S.A. de C.V. (812811884)