ALUMIER MD SHEER HYDRATION BROAD SPECTRUM SPF40 UNTINTED- titanium dioxide, zinc oxide cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Titanium Dioxide 7%, Zinc Oxide 6.28%,    Sunscreen

Available from:

CSR Cosmetic Solutions Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- helps prevent sunburn

Authorization status:

OTC monograph not final

Summary of Product characteristics

ALUMIER MD SHEER HYDRATION BROAD SPECTRUM SPF40 UNTINTED-
TITANIUM DIOXIDE, ZINC OXIDE CREAM
CSR COSMETIC SOLUTIONS 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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ALUMIER MD SHEER HYDRATION BROAD SPECTRUM SPF40 UNTINTED
DRUG FACTS
ACTIVE INGREDIENTS
Titanium Dioxide 7%
Zinc Oxide 6.28%
PURPOSE
Sunscreen
USE
helps prevent sunburn
WARNINGS
FOR EXTERNAL USE ONLY.
WHEN USING THIS PRODUCT
do not use on damaged or broken skin
keep out of eyes. Rinse with water to remove.
STOP USE AND ASK A DOCTOR
If you develop severe irritation, burning or itching of the skin,
hives, swelling of eyes and
mouth, blistering or difficulty breathing
KEEP OUT OF REACH OF CHILDREN.
If swallowed, call a Poison Control Centre or get medical help right
away.
DIRECTIONS
apply liberally/generously (and evenly) 15 minutes before sun exposure
reapply at least every 2 hours
for use on children less than 6 months of age consult a health care
practitioner
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
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
use a water resistant sunscreen if swimming or sweating
OTHER INFORMATION
Do not use if security seal is broken or missing.
You may report a serious adverse reaction event from using this
product to: Alumier
Labs Inc., 550 Cochituate Road, Suit 25, Framingham, MA 01701
INACTIVE INGREDIENTS
1911023 - Water/Aqua, C12-15 Alkyl Benzoate, Caprylic/Capric
Triglyceride, Propanediol,
Butylocyl Salicylate, Cetearyl Alcohol, Aluminium Stearate, Glycerin,
Glyceryl Stearate,
PEG-100 Stearate, Lecithi