Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 5c3d1a2b-28f1-4b8a-a018-dcbe3b12ea62
Route
TOPICAL
Published
Effective Date 2010-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (80 mg) Octinoxate (70 mg) Enzacamene (35 mg) Avobenzone (10 mg)
Inactive Ingredients
Water Glycerin Butylene Glycol Ceteth-10 Polyoxyl 100 Stearate Sorbitan Monooleate Magnesium Stearate Diglycol Stearate Magnesium Sulfate Heptahydrate Olive Oil Isopropyl Myristate Methylparaben Propylparaben Diazolidinylurea

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-04-23
Description

Zinc Oxide, Octinoxate, Enzacamene, Avobenzone

Medication Information

Description

Zinc Oxide, Octinoxate, Enzacamene, Avobenzone

Section 50565-1
Keep out of reach of children
Section 50566-9
Stop use and ask a doctor if rash or irritation develops and lasts.
Section 50567-7
Apply liberally before skin exposure;

Reapply as needed after swimming.
Section 51945-4
Section 55105-1
Helps prevent sunburn;

Higher SPF gives more sunburn protection;

Retain SPF after 40 minutes activity in the water;

Rinse with soap to remove.
Section 55106-9
Zinc Oxide, Octinoxate, Enzacamene, Avobenzone
Warning
For external use only;

Avoid contact with eyes;

Stop use and ask a doctor if rash or irritation develops and lasts;

Keep out of reach of children.
Ask Doctor
Stop use and ask a doctor if rash or irritation develops and lasts.

Children under 6 months of age: ask a doctor;

Structured Label Content

Section 50565-1 (50565-1)
Keep out of reach of children
Section 50566-9 (50566-9)
Stop use and ask a doctor if rash or irritation develops and lasts.
Section 50567-7 (50567-7)
Apply liberally before skin exposure;

Reapply as needed after swimming.
Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Helps prevent sunburn;

Higher SPF gives more sunburn protection;

Retain SPF after 40 minutes activity in the water;

Rinse with soap to remove.
Section 55106-9 (55106-9)
Zinc Oxide, Octinoxate, Enzacamene, Avobenzone
Warning
For external use only;

Avoid contact with eyes;

Stop use and ask a doctor if rash or irritation develops and lasts;

Keep out of reach of children.
Ask Doctor
Stop use and ask a doctor if rash or irritation develops and lasts.

Children under 6 months of age: ask a doctor;

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:02.400025 · Updated: 2026-03-14T22:52:21.082332