RESTORATIVE ELEMENTS EVEN DEFENSE SPF 30- homosalate, octocrylene, octisalate, and avobenzone cream

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), Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W), Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)

Available from:

Alchemee, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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. ■ Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Directions ■ apply liberally 15 minutes before sun exposure ■ 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

Authorization status:

OTC monograph final

Summary of Product characteristics

RESTORATIVE ELEMENTS EVEN DEFENSE SPF 30- HOMOSALATE, OCTOCRYLENE,
OCTISALATE, AND AVOBENZONE CREAM
ALCHEMEE, 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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RESTORATIVE ELEMENTS™ EVEN DEFENSE SPF 30
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Avobenzone 3%
Homosalate 12.50%
Octisalate 5%
Octocrylene 8%
_PURPOSE_
SUNSCREEN
_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. ■ KEEP OUT OF REACH OF
CHILDREN. If product is swallowed,
get medical help or contact a
Poison Control Center right away.
_DIRECTIONS_ ■ apply liberally
15 minutes before sun exposure
■ 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 ■ children under
6 months of age: Ask a doctor.
_OTHER INFORMATION_
■ protect the product in this
container from excessive heat
and direct sun
■ may stain some fabrics.
_INACTIVE INGREDIENTS_
water, niacinamide, C12-15 alkyl
benzoate, silica, butylene glycol,
styrene/acrylates copolymer,
isododecane, sorbitol, cetearyl
alcohol, glycerin, kojic acid,
phenoxyethanol, dimethicone,
glyceryl stearate, PEG-100 stearate,
ceteareth-20, phenylethyl
resorcinol, carbomer, sorbitan
stearate, glycyrrhiza glabra (licorice