ALOE ICE SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)

Available from:

Aloe Care International, LLC

INN (International Name):

AVOBENZONE

Composition:

AVOBENZONE 3 g in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

PURPOSE: SUNSCREEN INDICATIONS: HELPS PREVENT SUNBURN

Authorization status:

OTC monograph not final

Summary of Product characteristics

ALOE ICE SPF 50- AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,
OXYBENZONE LOTION
ALOE CARE INTERNATIONAL, LLC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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ACTIVE INGREDIENTS:
AVOBENZONE (3%)
HOMOSALATE (5%)
OCTINOXATE (6%)
OCTISALATE (5%)
OCTOCRYLENE (10%)
PURPOSE:
SUNSCREEN
INDICATIONS:
HELPS PREVENT SUNBURN
DIRECTIONS:
APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
REAPPLY: AFTER 40 MINUTES OF SWIMMING OR SWEATING; IMMEDIATELY AFTER
TOWEL DRYING; AT LEAST EVERY 2 HOURS.
KEEP OUT OF REACH OF CHILDREN.
WARNINGS:
FOR EXTERNAL USE ONLY. 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 A 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.
Other Ingredients:
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALLANTOIN, ALOE
BARBADENSIS LEAF JUICE, ALUMINUM STARCH OCTENYLSUCCINATE, BUTYLOCTYL
SALICYLATE, C12-15 ALKYL BENZOATE, CAMELLIA SINENSIS LEAF EXTRACT,
CARBOMER, IODOPROPYNYL BUTYLCARBAMATE, ISODECYL DEOPENTANOATE,
METHYLISOTHIAZOLINONE, PHENOXYETHANOL, POLYETHYLENE, POLYSORBATE 20,
PROPANEDIOL, SORBITOL, THEOBROMA CACAO (COCOA) SEED BUTTER, TOCOPHERYL
ACETATE, TRIETHANOLAMINE, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, WATER
ALOE ICE SPF 50
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 1477-20 3
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)
AVOBENZONE
3 g in 10 0 mL
HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)
HOMOSALATE
5 g in 10 0 mL
O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)
OCTINOXATE
6 g in 10 0 mL
O CTISALATE (UN