Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID c6172413-b5b1-4eab-8cc7-bacf5670acf3
Route
TOPICAL
Published
Effective Date 2012-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.5 mg)
Inactive Ingredients
Cyclomethicone 5 Cyclomethicone 6 Titanium Dioxide Octinoxate Glycerin Dipropylene Glycol Hexyl Laurate Butylene Glycol Dicaprylate/dicaprate Cetyl Peg/ppg-10/1 Dimethicone (hlb 1.5) Bentonite Chrysanthellum Indicum Flower Oil Magnesium Sulfate Zinc Oxide Magnolia Liliiflora Flower Convallaria Majalis Bulb Shea Butter Magnolia Kobus Bark Thujopsis Dolabrata Whole Bancha Tea Leaf/twig Pummelo Centella Asiatica Alcea Rosea Flower Aloe Vera Leaf Triethoxycaprylylsilane Ferric Oxide Yellow Ferric Oxide Red Ferrosoferric Oxide Sorbitan Isostearate .alpha.-tocopherol Acetate Ascorbyl Glucoside Lilium Candidum Flower Ceramide 3 Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-09-27
Description

allantoin

Medication Information

Warnings and Precautions
When using this product

- keep out of eyes, ears, and mouth.  If contact occurs, rinse with plenty of cold water right away and contact a physician.  If swallowing, drink plenty of water and contact a physician
Indications and Usage
After basic skin care routine, apply evenly to your face
Dosage and Administration
for external use only
Description

allantoin

Section 50565-1
keep out of reach of the children
Section 51727-6
water, cyclopentasiloxane, cyclohexasiloxane, titanium dioxide, ethylhexyl methoxycinnamate, glycerin, dipropylene glycol, hexyl laurate, butylene glycol dicaprylate / dicaprate, cytyl peg/ppg-10/1 dimethicone, bentonite, chrysanthellum indicum extract, magnesium sulfate, zinc oxide, pearl powder, magnolia liliflora flower extract, lilium candidum flower extract, convallaria majalis bulb/root extract, shea butter, magnolia kobus bark extract, ghujopsis dolabrata branch extract, camellia sinensis leaf extract, grapefruit fruit extract, centella asiatica extract, althaea rosea flower extract, aloe barbadensis leaf extract, silica, triethoxycaprylsilane, ci 77492, ci 77491, ci 44299, ultramarines, sorbitan siostearate, tocopheryl acetate, ascorbyl glucoside, lilium candidum flower extract, ceramide 3, disodium edta, methylparaben, propylparaben, fragrance

Section 51945-4
Section 55105-1
UVB, UVA protection

Section 55106-9
allantoin

Structured Label Content

Indications and Usage (34067-9)
After basic skin care routine, apply evenly to your face
Dosage and Administration (34068-7)
for external use only
Warnings and Precautions (34071-1)
When using this product

- keep out of eyes, ears, and mouth.  If contact occurs, rinse with plenty of cold water right away and contact a physician.  If swallowing, drink plenty of water and contact a physician
Section 50565-1 (50565-1)
keep out of reach of the children
Section 51727-6 (51727-6)
water, cyclopentasiloxane, cyclohexasiloxane, titanium dioxide, ethylhexyl methoxycinnamate, glycerin, dipropylene glycol, hexyl laurate, butylene glycol dicaprylate / dicaprate, cytyl peg/ppg-10/1 dimethicone, bentonite, chrysanthellum indicum extract, magnesium sulfate, zinc oxide, pearl powder, magnolia liliflora flower extract, lilium candidum flower extract, convallaria majalis bulb/root extract, shea butter, magnolia kobus bark extract, ghujopsis dolabrata branch extract, camellia sinensis leaf extract, grapefruit fruit extract, centella asiatica extract, althaea rosea flower extract, aloe barbadensis leaf extract, silica, triethoxycaprylsilane, ci 77492, ci 77491, ci 44299, ultramarines, sorbitan siostearate, tocopheryl acetate, ascorbyl glucoside, lilium candidum flower extract, ceramide 3, disodium edta, methylparaben, propylparaben, fragrance

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
UVB, UVA protection

Section 55106-9 (55106-9)
allantoin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:31.487668 · Updated: 2026-03-14T22:53:16.318838