EAD- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)

MAH:

EUROPEAN PERFUME WORKS CO. LLC

administration_route:

TOPICAL

prescription_type:

OTC DRUG

therapeutic_indication:

Sunscreen - 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.

authorization_status:

OTC monograph not final

SPC

EAD- AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
LOTION
EUROPEAN PERFUME WORKS CO. 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._
----------
EAD
_ACTIVE INGREDIENTS_
Avobenzone 2.0%
Homosalate 12.0%
Octisalate 5.0%
Octocrylene 2.0%
Oxybenzone 2.0%
_PURPOSE_
Sunscreen
KEEP OUT OF REACH OF CHILDREN.
If product is swallowed, get medical help or contact a Poison Control
Center right away.
_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_
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.
_DIRECTIONS_
apply liberally 15 minutes before sun exposure
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 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-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor
_INACTIVE INGREDIENTS_
amyl cinnamal, ascorbyl palmitate, benzyl alcohol, butylparaben,
C12-15 alkyl benzoate,
carbomer, ceteareth-20, cetearyl alcohol, ethylparaben, fragrance,
glyceryl stearate, glyceryl
stearate SE, isobutylparaben, linalool, methylparaben, PEG-100
stearate, phenoxyethanol,
propylene glycol, propylparaben, sodium hydroxide, sodium cetearyl
sulfate, tetrasodium
EDTA, tocopheryl acetate, water.
_OTHER INFORMATION_
protect this product from excessive heat and direct sun.
_QUESTIONS OR COMMENTS?_
Call toll free 1-844-875-4176 (Mon-Fri