PREVENTION CLEAR SOLAR GEL SPF30- avobenzon, octisalate and octocrylene cream

Prevention Clear Solar Gel SPF30 by

Drug Labeling and Warnings

Prevention Clear Solar Gel SPF30 by is a Otc medication manufactured, distributed, or labeled by Allure LAbs, Allure Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Avobenzone 2.5%

Octisalate 5%

Octocrylene 10%

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 15 minutes before sun exposure children under 6 months of age: Ask a doctor 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 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, POLYSILICONE-11, DIMETHICONE, SQUALANE, BUTYLOCTYL SALICYLATE, DIVINYLDIMETHICONE/DIMETHICONE/ PHENYLSILSESQUIOXANE CROSSPOLYMER, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, LIMONENE, CAMELLIA OLEIFERA SEED OIL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, ALOE BARBADENSIS LEAF EXTRACT, PRUNUS ARMENIACA (APRICOT) KERNEL OIL, TETRAHEXYLDECYL ASCORBATE, TOCOPHERYL ACETATE, CITRIC ACID.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREVENTION CLEAR SOLAR GEL SPF30 
avobenzon, octisalate and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4226
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LIMONENE, (+)- (UNII: GFD7C86Q1W)
SAFFLOWER OIL (UNII: 65UEH262IS)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SQUALANE (UNII: GW89575KF9)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER (UNII: T3064TZ75A)
CAMELLIA OIL (UNII: T1PE06G0VE)
DIMETHICONE (UNII: 92RU3N3Y1O)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
ORANGE OIL (UNII: AKN3KSD11B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4226-1	7 g in 1 TUBE; Type 0: Not a Combination Product	01/06/2023
2	NDC: 62742-4226-3	1 in 1 CARTON	01/06/2023
2	NDC: 62742-4226-2	42.5 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	01/06/2023

Labeler - Allure LAbs (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4226)