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

Active Ingredient
Zinc Oxide, Octinoxate, Enzacamene, Avobenzone
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.
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

Active Ingredient (55106-9)
Zinc Oxide, Octinoxate, Enzacamene, Avobenzone
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.
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