Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 4918be5e-2b9e-4b29-9000-fb97ffb5e1a8
Route
TOPICAL
Published
Effective Date 2010-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Octisalate (50 mg) Oxybenzone (35 mg) Avobenzone
Inactive Ingredients
Water Glycerin Cetostearyl Alcohol Glyceryl Monostearate Cyclomethicone Polysorbate 80 Ethylhexyl Palmitate Sodium Lauryl Sulfate Carbomer 934 Trolamine Methylparaben Propylparaben Diazolidinyl Urea

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-07-20
Description

Octinoxate, Octisalate, Oxybenzone, Avobenzone 

Medication Information

Description

Octinoxate, Octisalate, Oxybenzone, 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 50569-3
Stop use and ask a doctor if rash or irritation develops and lasts;

Children under 6 months of age: ask a doctor;

Section 50570-1
Avoid contact with eyes;

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

Section 51945-4


Active Ingredients                                             Purpose

Octinoxate          7.50%    ………………………………… Absorb/Reflect UV rays

Octisalate          5.00%    ………………………………… Absorb/Reflect UV rays

Oxybenzone          3.50%    ………………………………… Absorb/Reflect UV rays

Avobenzone          3.50%    ………………………………… Absorb/Reflect UV rays

Uses:

■ Helps prevent sunburn;

■ Higher SPF gives more sunburn protection;

■ Rinse with water 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

Directions for use:

■ Apply liberally before skin exposure;

■ Children under 6 months of age: ask a doctor;

■ Reapply as needed after swimming.

Inactive Ingredients:

Water, Glycerin, Cetostearyl Alcohol, Glyceryl Monostearate, Cyclomethicone, Polysorbate 80

Ethylhexyl Palmitate, Sodium Lauryl Sulfate, Carbomer 934, Trolamine, Methylparaben, Propylparaben

Diazolidinylurea



Distributed By:

ePromos Promotional Products, Inc.

ph: 212 457 3906





Made in China
Section 55105-1
Helps prevent sunburn;

Higher SPF gives more sunburn protection;

Rinse with water to remove;

Section 55106-9
Octinoxate, Octisalate, Oxybenzone, Avobenzone 

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 50569-3 (50569-3)
Stop use and ask a doctor if rash or irritation develops and lasts;

Children under 6 months of age: ask a doctor;

Section 50570-1 (50570-1)
Avoid contact with eyes;

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

Section 51945-4 (51945-4)


Active Ingredients                                             Purpose

Octinoxate          7.50%    ………………………………… Absorb/Reflect UV rays

Octisalate          5.00%    ………………………………… Absorb/Reflect UV rays

Oxybenzone          3.50%    ………………………………… Absorb/Reflect UV rays

Avobenzone          3.50%    ………………………………… Absorb/Reflect UV rays

Uses:

■ Helps prevent sunburn;

■ Higher SPF gives more sunburn protection;

■ Rinse with water 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

Directions for use:

■ Apply liberally before skin exposure;

■ Children under 6 months of age: ask a doctor;

■ Reapply as needed after swimming.

Inactive Ingredients:

Water, Glycerin, Cetostearyl Alcohol, Glyceryl Monostearate, Cyclomethicone, Polysorbate 80

Ethylhexyl Palmitate, Sodium Lauryl Sulfate, Carbomer 934, Trolamine, Methylparaben, Propylparaben

Diazolidinylurea



Distributed By:

ePromos Promotional Products, Inc.

ph: 212 457 3906





Made in China
Section 55105-1 (55105-1)
Helps prevent sunburn;

Higher SPF gives more sunburn protection;

Rinse with water to remove;

Section 55106-9 (55106-9)
Octinoxate, Octisalate, Oxybenzone, Avobenzone 

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:05.822711 · Updated: 2026-03-14T22:52:25.436081