ZO SKIN HEALTH ORASER ANTI-AGING HAND CARE PROGRAM CORRECT, PROTECT AND PREVENT AGING HANDS- avobenzone, octinoxate, and oxybenz

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX), Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51), Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)

Available from:

ZO Skin Health, Inc.

INN (International Name):

Avobenzone

Composition:

Avobenzone 30 mg in 1 mL

Prescription type:

OTC DRUG

Therapeutic indications:

- Helps prevent sunburn - If used as directed with other sun protection measures (see Directions ) decreases the risk of of skin cancer and early aging caused by the sun.

Authorization status:

OTC monograph final

Summary of Product characteristics

                                ZO SKIN HEALTH ORASER ANTI-AGING HAND CARE PROGRAM CORRECT,
PROTECT AND PREVENT AGING HANDS- AVOBENZONE, OCTINOXATE, AND
OXYBENZONE
ZO SKIN HEALTH, 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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ZO SKIN HEALTH ORASER ANTI-AGING HAND CARE PROGRAM CORRECT, PROTECT
AND
PREVENT AGING HANDS
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_PURPOSE_
Avobenzone 3.0%
Sunscreen
Octinoxate 7.5%
Sunscreen
Oxybenzone 2.0%
Sunscreen
US ES
Helps prevent sunburn
If used as directed with other sun protection measures (see
_DIRECTIONS_) decreases the risk of of skin
cancer and early aging caused by the sun.
WARNINGS
FOR EXTERNAL USE ONLY.
DO NOT USE on damaged skin.
WHEN USING THIS PRODUCT keep out of eyes. Rinse with water to remove.
STOP USING THIS PRODUCT IF skin rash occurs.
KEEP OUT OF REACH OF CHILDREN. If swallowed get medical help or
contact a Poison Control Center right
away.
DIRECTIONS
Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
Children under 6 months: Ask a doctor
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:
-
-
OTHER INFORMATION
Protect the product in this container from excessive heat and direct
sunlight
You may report a serious adverse reaction event from using this
product to ZO Skin Health, Inc. 1
Technology Drive, Irvine, CA 92618
®
®
Limit time in the sun, especially from 10 a.m. - 2 p.m.
Wear long-sleeved shirts, pants, hats and sunglasses
INACTIVE INGREDIENTS
Water (Aqua), Caprylic/Capric Triglyceride, Glycerin, C12-15 Alkyl
Benzoate, Butyrospermum Parkii
(Shea) Butter, Cetearyl Alcohol, Styrene/Acrylates Copolymer,
Butyloctyl Salicylate, Pentylene
Glycol, Pol
                                
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