MILANI PRIME PROTECT SPF 30 FACE PRIMER- avobenzone, octinoxate, octocrylene, and oxybenzone cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)

Available from:

The Milani Group, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

MILANI PRIME PROTECT SPF 30 FACE PRIMER- AVOBENZONE, OCTINOXATE,
OCTOCRYLENE, AND OXYBENZONE CREAM
THE MILANI GROUP, 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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MILANI PRIME PROTECT SPF 30 FACE PRIMER
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_PURPOSE_
_Avobenzone 3.0%_
_Sunscreen_
_Octinoxate 7.3%_
_Sunscreen_
_Octocrylene 3.0%_
_Sunscreen_
_Oxybenzone 2.0%_
_Sunscreen_
USES
Helps prevent sunburn
If used as directed with other sun protection (see Directions),
decreases the risk of
skin cancer and early skin aging caused by 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 swallowed, get medical help or
contact a Poison
Control Center right away.
DIRECTIONS
_FOR SUNSCREEN USE:_
Apply generously and evenly 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 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, and sun glasses
Children under 6 months of age: Ask a doctor.
OTHER INFORMATION
Protect the product in this container from excessive heat and direct
sun
INACTIVE INGREDIENTS
water, glycerin, isohexadecane, sodium acrylate/sodium
acryloyldimethyl taurate
copolymer, PEG-8, phenoxyethanol, polysorbate 80, xanthan gum,
tocopherol,
ethylhexylglycerin, citric acid, retinyl palmitate, disodium EDTA,
glycine soja (soybean) oil,
yellow 5 (CI 19140), red 40 (CI 16035).
QUESTIONS OR COMMENTS?
CALL 866–789–8002 MONDAY – FRIDAY (8 a.m.