PREVENTION SUN SERUM SPF30- zinc oxide cream

Prevention Sun Serum SPF30 by

Drug Labeling and Warnings

Prevention Sun Serum SPF30 by is a Otc medication manufactured, distributed, or labeled by Allure Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Zinc Oxide 15.6%

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

Shake well before use apply generously 15 minutes before sun exposure children under 6 months of age: Ask a doctor reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating 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 and other sun protection measures including: limit time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeved shirts, pants, hats and sunglasses

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

Inactive ingredients:

ISODODECANE, SQUALANE, POLYSILICONE-11, PROPANEDIOL DICAPRYLATE/CAPRATE, POLYGLYCERYL-3 POLYRICINOLEATE, POLYHYDROXYSTEARIC ACID, TRIETHOXYCAPRYLYLSILANE, LECITHIN, TOCOPHERYL ACETATE, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, LIMONENE, CAMELLIA OLEIFERA SEED OIL, TETRAHEXYLDECYL ASCORBATE, PRUNUS ARMENIACA (APRICOT) KERNEL OIL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, ALOE BARBADENSIS LEAF EXTRACT, CITRAL, LINALOOL, CITRIC ACID.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREVENTION SUN SERUM SPF30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4225
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ORANGE OIL (UNII: AKN3KSD11B)
GINGER (UNII: C5529G5JPQ)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CITRAL (UNII: T7EU0O9VPP)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SAFFLOWER OIL (UNII: 65UEH262IS)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SQUALANE (UNII: GW89575KF9)
CAMELLIA OIL (UNII: T1PE06G0VE)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPANEDIOL DICAPRYLATE/CAPRATE (UNII: F53961BX4F)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
APRICOT KERNEL OIL (UNII: 54JB35T06A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4225-1	7 g in 1 TUBE; Type 0: Not a Combination Product	01/05/2023
2	NDC: 62742-4225-3	1 in 1 CARTON	01/05/2023
2	NDC: 62742-4225-2	28.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	01/05/2023

Labeler - Allure Labs (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4225)