PANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC- octinoxate, octisalate, octocrylene, and zinc oxide lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)

Available from:

Prime Enterprises, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Sunscreen

Authorization status:

OTC monograph final

Summary of Product characteristics

PANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC- OCTINOXATE,
OCTISALATE,
OCTOCRYLENE, 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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_ACTIVE INGREDIENTS_ Octinoxate 5%, Octisalate 5%, Octocrylene 2%,
Zinc Oxide 3%
PURPOS E
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
PRODUCTkeep out of eyes. Rinse with water to remove. • STOP USE AND
ASK A DOCTORif 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 with a broad 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-sleeve shirts, pants, hats, and
sunglasses •children under 6 months: Ask a doctor.
INACTIVE INGREDIETS
Aluminium Starch Octenylsuccinate, Bis-PEG-12 Dimethicone Beeswax,
Cetyl PEG/PPG-10/1
Dimethicone, Decyl Glucoside, Diazolidinyl Urea, Diisodecyl Adipate,
Disodium EDTA, Glycerin,
Hexyl Laurate, Hydrogenated Castor Oil, Methylparaben, Mineral Oil,
Polyethylene, Polyglyceryl-4
Isostearate, Propylene Glycol, Propylparaben, Silica, Sodium Chloride,
Tocopheryl Acetate,
Triethoxycaprylysilane, Water
_OTHER INFORMATION_ Protect this product from excessive heat and
direct sun
Distributed by: Pan