SPF 30 SUNSCREEN- zinc oxide, titanium dioxide lotion 
CLEURE

----------

Cleure SPF 30 Sunscreen

ACTIVE INGREDIENT

Zinc oxide 9%

Titanium Dioxide 4.51%

PURPOSE

Sunscreen

USES

• helps prevent sunburn • If used as directed
with other sun protection measutes 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 doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact
a Poison Control Center right away.

DIRECTIONS

Apply liberally 15 minutes before
sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying• at least every 2 hours • Children under 6 months of age: 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 a Broad Spectrum SPF of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. - 2pm • wear long-sleeved shirts, pants, hats and sunglasses.

INACTIVE INGREDIENTS

Water, Caprylic / Capric Triglyceride, Cetearyl Alcohol, STEARETH-2, Glycerin, STEARETH-21, Aloe Vera, Dimethicone, Phenoxyethanol, Sodium Stearoyl Glutamate, Xanthan Gum, Disodium EDTA, Ethylhexylglycerin

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

Label

SPF 30 SUNSCREEN 
zinc oxide, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83294-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.51 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
STEARETH-21 (UNII: 53J3F32P58)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
STEARETH-2 (UNII: V56DFE46J5)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83294-101-18118 mL in 1 TUBE; Type 0: Not a Combination Product08/22/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/22/2022
Labeler - CLEURE (116355659)

Revised: 12/2023
Document Id: 0d825267-d5d6-8e03-e063-6294a90a1487
Set id: f5512f34-08ee-b0f6-e053-2a95a90ab5bd
Version: 2
Effective Time: 20231227
 
CLEURE