AMORA WHIP SCREEN SPF 30- homosalate, octocrylene, octisalate, octinoxate, ensulizole, titanium dioxide aerosol, foam

Amora Whip Screen SPF 30 by

Drug Labeling and Warnings

Amora Whip Screen SPF 30 by is a Otc medication manufactured, distributed, or labeled by I World LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Homosalate 5.6%, Octocrylene 4.7%, Octisalate 4.7%, Octinoxate 4.7%, Ensulizole 3.8%, Titanium dioxide 1.6%.

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

For external use only.

Skin cancer/skin aging alert  Spending time in the sun increases your risk of skin cancer and early skin aging.

This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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.

• If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply generously and evenly 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.
• Children under 6 month: ask a doctor.

Other information

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

Inactive ingredients

WATER (AQUA), GLYCERIN, PROPYLENE GLYCOL, ISODODECANE, STEARIC ACID, LAURIC ACID, BUTANE, POTASSIUM HYDROXIDE, PROPANE, ISOBUTANE, GLYCERYL STEARATE, PHENOXYETHANOL, PEG-100 STEARATE, LACTOBACILLUS FERMENT, SILICA, ALOE BARBADENSIS LEAF JUICE, SODIUM CITRATE, FRAGRANCE (PARFUM), ETHYLHEXYLGLYCERIN, CENTELLA ASIATICA EXTRACT, SACCHAROMYCES FERMENT FILTRATE, TOCOPHERYL ACETATE, BHT, 1,2-HEXANEDIOL, HYDROXYACETOPHENONE, OPUNTIA FICUS-INDICA EXTRACT, SODIUM HYALURONATE, ALPHA- ISOMETHYL IONONE, COUMARIN.

Questions or comments?

1-212-244-5170

Package Labeling:

INGREDIENTS AND APPEARANCE

AMORA WHIP SCREEN SPF 30 
homosalate, octocrylene, octisalate, octinoxate, ensulizole, titanium dioxide aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85179-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	56 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	47 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	47 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	47 mg  in 1 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	38 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (CI 77891 - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	16 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISODODECANE (UNII: A8289P68Y2)
STEARIC ACID (UNII: 4ELV7Z65AP)
LAURIC ACID (UNII: 1160N9NU9U)
BUTANE (UNII: 6LV4FOR43R)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPANE (UNII: T75W9911L6)
ISOBUTANE (UNII: BXR49TP611)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-100 STEARATE (UNII: YD01N1999R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
OPUNTIA FICUS-INDICA WHOLE (UNII: 23Z87HTQ6P)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
COUMARIN (UNII: A4VZ22K1WT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85179-000-00	113 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/02/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/02/2025

Labeler - I World LLC (830590126)