Drug Facts

Active Ingredient

Zinc Oxide 22%

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

Directions

apply liberally 15 minutes before sun exposure.
reapply at least every 2 hours
use a water-resistant sunscreen if swimming or sweating
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: Sun Protection Measures.
limit time in the sun, especially from 10am-2pm
wear long-sleeved shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor

Other Information

protect this product from excessive heat and direct sun

Inactive Ingredients

Acetyl Tetrapeptide-2, Allantoin, Artemisia Vulgaris Extract, Benzyl Alcohol, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Olivate, Coco-Caprylate, Ethylhexylglycerin, Iron Oxides, Laminaria Digitata Extract, Mixed Tocopherols, Panthenol, Polyhydroxystearic Acid, Saccharide Isomerate, Sorbitan Olivate, Stearyl Octyldodecyl Citrate Crosspolymer, Tetrasodium Glutamate Diacetate, Tocopherol, Water (Aqua), Xanthan Gum, Zingiber Officinale Root Oil.

Questions or Comments?

Call toll free 1-866-222-4620

Package Labeling:

Tube

SUZANNE ORGANICS TINTED MINERAL SUNSCREEN BROAD SPECTRUM SPF 25 - SAND
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:15435-300
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	220 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
GINGER OIL (UNII: SAS9Z1SVUK)
ACETYL TETRAPEPTIDE-2 (UNII: M24S4WZS8J)
ALLANTOIN (UNII: 344S277G0Z)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
COCO-CAPRYLATE (UNII: 4828G836N6)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
PANTHENOL (UNII: WV9CM0O67Z)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:15435-300-04	60 mL in 1 TUBE; Type 0: Not a Combination Product	10/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	10/01/2022

Labeler - SLC Skincare (117453517)

Suzanne Organics Tinted Mineral Sunscreen Broad Spectrum SPF 25 - Sand