MILANI SPF BFF 30 PRIMER- avobenzone, octinoxate, octocrylene, 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:

New Milani Group, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

MILANI SPF BFF 30 PRIMER- AVOBENZONE, OCTINOXATE, OCTOCRYLENE,
OXYBENZONE CREAM
NEW MILANI GROUP, LLC
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MILANI SPF BFF 30 PRIMER
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Avobenzone 3%, Octinoxate 7.3% Octocrylene 3% Oxybenzone 2%
_PURPOSE_
Sunscreen
_USES_
helps prevent sunburn
if used as directed with other sun protection measures (see ),
decreases the risk of
skin cancer and early skin aging caused by the sun _DIRECTIONS_
_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_
apply generously and evenly 15 minutes before sun exposure
reapply at least every 2 hours
use a water-resistant sunscreen if swimming or sweating
children under 6 months of age: Ask a doctor.
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: SUN PROTECTION
MEASURES.
limit time in the sun, especially from 10 a.m.-2 p.m.
wear long-sleeved shirts, pants, and sunglasses
_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, Polysorbate 80, Xanthan Gum, Tocopherol, Glycine
Soja (Soybean)
Oil, Retinyl Palmitate, Ethylhexylglycerin, Citric Acid, Disodium
EDTA, Phenoxyethanol,
Yellow 5, Red 40.
QUESTIONS OR COMMENTS?
Call 866-789-8002 Monday - Friday (7 a.m. to 3:30 p.m. PST)
PACKAGE LABELING:
MILANI SPF BFF 30 PRIMER
avobenzone, octinoxate, octocrylene, oxybenzone cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:71435-0001
ROUTE OF ADMINISTRATION
TOPICAL
New Milani Group, LLC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE