Drug Facts

Active ingredients

Titanium dioxide 6.5%

Zinc oxide 6%

Purpose

Sunscreen

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

For external use only.

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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

protect the product in this container from excessive heat and direct sun

Inactive ingredients

Benzoic Acid, Cetyl Alcohol, Chlorophenesin, Deionized Water, Glyceryl Caprylate/Caprate, Glyceryl Stearate, Glycerine, Sorbic Acid Phenoxyethanol, VP/

Questions?

Toll-free 1-844-KIINSUN

Package Labeling:

Package Label

KIINSUN SUNSCREEN BROAD SPECTRUM SPF50
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72431-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72431-001-01	165 g in 1 TUBE; Type 0: Not a Combination Product	01/02/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/02/2020

Labeler - Grupo Pogami, S.A. de C.V. (812811884)

KiinSun Sunscreen Broad Spectrum SPF50