CLEARLY ZINQ TINTED HYDRATING FACIAL SPF GROWTH FACTOR 35- zinc oxide cream

Clearly Zinq Tinted Hydrating Facial SPF Growth Factor 35 by

Drug Labeling and Warnings

Clearly Zinq Tinted Hydrating Facial SPF Growth Factor 35 by is a Otc medication manufactured, distributed, or labeled by Allure Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients:

Zinc Oxide 20.28%

PURPOSE

Purpose: Sunscreen

INDICATIONS & USAGE

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

Warnings: For external use only.

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a 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.

DOSAGE & ADMINISTRATION

Directions Apply generously and evenly15 minutes before sun exposure. Reapply: after 80 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 time in the sun, especially from 10 a.m. -2 p.m., wear long-sleeved shirts, pants, hats and sunglasses Children under 6 months of age: Ask a doctor.

OTHER SAFETY INFORMATION

Other information protect this product from excessive heat and direct sun.

INACTIVE INGREDIENT

Inactive ingredients:

Isododecane, Polysilicone-11, C13-15 Alkane, Butyloctyl Salicylate, Propanediol Dicaprylate/Caprate, Dimethicone, Polyhydroxystearic Acid, Castor oil/IPDI Copolymer, Dilinoleic Acid/Butanediol Copolymer, Disodium Stearoyl Glutamate, Polyglyceryl-6 Polyricinoleate, Polyglyceryl-3 Polyricinoleate, Triethoxycaprylylsilane, Lecithin, Coco-Caprylate/Caprate, Camellia Oleifera (Seed) Oil, Kinetin, Prunus Armeniaca (Apricot) Kernel Oil, Squalane,Aloe Barbadensis Leaf Extract, Carthamus Tinctorius (Safflower) Seed Oil, Hydrated Silica, Tocopheryl Acetate, May Contain +/-, CI 77491 (Iron Oxide), CI 77492 (Iron Oxide), CI 77499 (Iron Oxide)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLEARLY ZINQ TINTED HYDRATING FACIAL SPF GROWTH FACTOR 35 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4259
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20.28 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
CASTOR OIL (UNII: D5340Y2I9G)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
C13-15 ALKANE (UNII: 114P5I43UJ)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
SAFFLOWER OIL (UNII: 65UEH262IS)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ISODODECANE (UNII: A8289P68Y2)
KINETIN (UNII: P39Y9652YJ)
CAMELLIA OIL (UNII: T1PE06G0VE)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
SQUALANE (UNII: GW89575KF9)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PROPANEDIOL DICAPRYLATE/CAPRATE (UNII: F53961BX4F)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
DILINOLEIC ACID/BUTANEDIOL COPOLYMER (UNII: 1F2S8T535O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4259-2	1 in 1 CARTON	04/04/2024
1	NDC: 62742-4259-1	48 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/04/2024

Labeler - Allure Labs (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4259)