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sunscreen

Humphreyline

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

Octinoxate (6.5%)

Octisalate (4.0%)

Octocrylene (7.0%)

Oxybenzone (5.5%)

Purpose

Sunscreen

For external use only.

Avoid contact with eyes.

Discontinue use if rash or irritation occurs.

Children under 6 months consult a doctor before use.

Children under 6 months consult a doctor before use.

Uses

For external use only.

Water, PPG-15 Stearyl Ether Benzoate, Corn Starch modified, Triethanolamine, Hypromellose, Acrylic Polymer, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Disodium EDTA

sunscreen

sunscreen

octinoxate, octisalate, octocrylene, oxybenzone LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:19392-400
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 65 mg
OXYBENZONE OXYBENZONE 55 mg
OCTISALATE OCTISALATE 40 mg
OCTOCRYLENE Octocrylene 70 mg

Inactive Ingredients

Ingredient Name Strength
water
STARCH, CORN
TROLAMINE
HYPROMELLOSES
POLYQUATERNIUM-39 (31/40/29 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1500000 MW)
propylene glycol
DIAZOLIDINYL UREA
METHYLPARABEN
EDETATE DISODIUM
PROPYLPARABEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:19392-400-03 28 in 1 BOTTLE, PLASTIC
2 NDC:19392-400-04 44 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2010-01-01


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