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

Suzanne Organics Tinted Mineral Sunscreen Broad Spectrum SPF 25 - Sand by

Drug Labeling and Warnings

Suzanne Organics Tinted Mineral Sunscreen Broad Spectrum SPF 25 - Sand by is a Otc medication manufactured, distributed, or labeled by SLC Skincare. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - SLC Skincare (117453517)