ABELLA COLORSHADE SPF 35 MEDIUM- octinoxate and zinc oxide lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

Available from:

Prime Enterprises Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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 final

Summary of Product characteristics

ABELLA COLORSHADE SPF 35 MEDIUM- OCTINOXATE AND ZINC OXIDE LOTION
PRIME ENTERPRISES INC.
_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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ABELLA SKIN CARE INC. COLORSHADE SPF 35 TINTED SUNSCREEN LOTION -
MEDIUM
_ACTIVE INGREDIENTS_
Octinoxate 3%
Zinc Oxide 3%
_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:
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 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-sleeved shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor
_INACTIVE INGREDIENTS_
Aloe Barbadensis Leaf Juice, Bentonite, Camellia Sinensis (Green Tea)
Leaf Extract, Caramel, Cetyl
Aloe Barbadensis Leaf Juice, Bentonite, Camellia Sinensis (Green Tea)
Leaf Extract, Caramel, Cetyl
Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Cholecalciferol,
Cyclomethicone, Disodium EDTA,
DMDM Hydantoin, Hexyl Laurate, Hydrogenated Castor Oil, Iron Oxides,
Isocetyl Stearate, Melanin,
Octyl Stearate, Polyethylene, Polyglyceryl-4 Isostearate, Propylene
Glycol, Prunus Amygdalus Dulcis
(Sweet Almond) Oil, Silica, Sodium Chloride, Titanium Dioxide,
Toco