PREVENTION SUN SERUM SPF 30 TINTED- zinc oxide cream

Prevention Sun Serum SPF 30 Tinted by

Drug Labeling and Warnings

Prevention Sun Serum SPF 30 Tinted 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

Directions 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, CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYHYDROXYSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, TRIETHOXYCAPRYLYLSILANE, LECITHIN, IRON OXIDES (CI 77492), HYDROGENATED PALM OIL, HYDROGENATED RAPESEED OIL, COCO-CAPRYLATE/CAPRATE, HYDRATED SILICA, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, LIMONENE, CAMELLIA OLEIFERA SEED OIL, TETRAHEXYLDECYL ASCORBATE, TOCOPHERYL ACETATE, POLYGLYCERYL-6 POLYRICINOLEATE, IRON OXIDES (CI 77491), DILINOLEIC ACID/BUTANEDIOL COPOLYMER, DISODIUM STEAROYL GLUTAMATE, AQUA/WATER/EAU, PRUNUS ARMENIACA (APRICOT) KERNEL OIL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CASTOR OIL/IPDI COPOLYMER, IRON OXIDES (CI 77499), SODIUM SULFATE, ALOE BARBADENSIS LEAF EXTRACT, CITRAL, LINALOOL, CITRIC ACID.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREVENTION SUN SERUM SPF 30 TINTED 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4224
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
ISODODECANE (UNII: A8289P68Y2)
HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CAMELLIA OIL (UNII: T1PE06G0VE)
SAFFLOWER OIL (UNII: 65UEH262IS)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
WATER (UNII: 059QF0KO0R)
PROPANEDIOL DICAPRYLATE/CAPRATE (UNII: F53961BX4F)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRAL (UNII: T7EU0O9VPP)
ORANGE OIL (UNII: AKN3KSD11B)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
SQUALANE (UNII: GW89575KF9)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
CASTOR OIL (UNII: D5340Y2I9G)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GINGER (UNII: C5529G5JPQ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYDROGENATED PALM OIL (UNII: 257THB963H)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
DILINOLEIC ACID/BUTANEDIOL COPOLYMER (UNII: 1F2S8T535O)
SODIUM SULFATE (UNII: 0YPR65R21J)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4224-1	7 g in 1 TUBE; Type 0: Not a Combination Product	01/04/2023
2	NDC: 62742-4224-3	1 in 1 CARTON	01/04/2023
2	NDC: 62742-4224-2	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	01/04/2023

Labeler - Allure Labs (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4224)