SPF 30 SUNSCREEN- zinc oxide, titanium dioxide lotion

SPF 30 Sunscreen by

Drug Labeling and Warnings

SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by CLEURE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

STORAGE AND HANDLING

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPF 30 SUNSCREEN 
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83294-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.51 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83294-101-18	118 mL in 1 TUBE; Type 0: Not a Combination Product	08/22/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/22/2022

Labeler - CLEURE (116355659)