Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 38ea04f6-ebb7-46b3-a157-7ce1271deb1f
Route
TOPICAL
Published
Effective Date 2024-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ethylhexyl Triazone (30 mg) Drometrizole Trisiloxane (50 mg) Homosalate (100 mg) Ecamsule (40 mg) Octisalate Bemotrizinol Diethylamino Hydroxybenzoyl Hexyl Benzoate
Inactive Ingredients
Water Glycerin Alkyl (c12-15) Benzoate Alcohol Starch, Corn Propylene Glycol Trolamine Sulfuric Acid Stearic Acid Peg-100 Stearate Caprylyl Glycol Glyceryl Monostearate Sodium Stearoyl Glutamate Soybean Oil Tocopherol Xanthan Gum Benzyl Salicylate Benzyl Alcohol Myristic Acid

Identifiers & Packaging

Marketing Status
EXPORT ONLY Active Since 2014-01-01

Description

Apply liberally and evenly onto face and/or body prior to sun exposure and massage into skin for complete coverage. Avoid the eye area. Leave ot dry and apply a second time to ensure a generous application. An insufficient amount of product reduces the level of protection. Re-apply frequently to maintain protection, especially after swimming, perspiring, or using a towel. Over-exposure to tht sun is dangerous. Keep babies and young children out of direct sunlight, and well covered. Do not stay too long in the sun, even while using a sunscreen product, because it does not provide you 100% protection. In case of contact with eyes, rinse them immediately and thoroughly.


Medication Information

Description

Apply liberally and evenly onto face and/or body prior to sun exposure and massage into skin for complete coverage. Avoid the eye area. Leave ot dry and apply a second time to ensure a generous application. An insufficient amount of product reduces the level of protection. Re-apply frequently to maintain protection, especially after swimming, perspiring, or using a towel. Over-exposure to tht sun is dangerous. Keep babies and young children out of direct sunlight, and well covered. Do not stay too long in the sun, even while using a sunscreen product, because it does not provide you 100% protection. In case of contact with eyes, rinse them immediately and thoroughly.

Section 51945-4

Directions

Apply liberally and evenly onto face and/or body prior to sun exposure and massage into skin for complete coverage. Avoid the eye area. Leave ot dry and apply a second time to ensure a generous application. An insufficient amount of product reduces the level of protection. Re-apply frequently to maintain protection, especially after swimming, perspiring, or using a towel. Over-exposure to tht sun is dangerous. Keep babies and young children out of direct sunlight, and well covered. Do not stay too long in the sun, even while using a sunscreen product, because it does not provide you 100% protection. In case of contact with eyes, rinse them immediately and thoroughly.

Ingredients

Ethylhexyl Triazone, Drometrizole Trisiloxane, Homosalate, Terephthalylidene Dicamphor Sulfonic Acid, Ethyhexyl Salicylate, Bis-Ethylhexyloxyphenol methoxyphenyl triazine, Diethylamino hydroxybenzoyl hexyl benzoate


Structured Label Content

Section 51945-4 (51945-4)

Directions

Apply liberally and evenly onto face and/or body prior to sun exposure and massage into skin for complete coverage. Avoid the eye area. Leave ot dry and apply a second time to ensure a generous application. An insufficient amount of product reduces the level of protection. Re-apply frequently to maintain protection, especially after swimming, perspiring, or using a towel. Over-exposure to tht sun is dangerous. Keep babies and young children out of direct sunlight, and well covered. Do not stay too long in the sun, even while using a sunscreen product, because it does not provide you 100% protection. In case of contact with eyes, rinse them immediately and thoroughly.

Ingredients

Ethylhexyl Triazone, Drometrizole Trisiloxane, Homosalate, Terephthalylidene Dicamphor Sulfonic Acid, Ethyhexyl Salicylate, Bis-Ethylhexyloxyphenol methoxyphenyl triazine, Diethylamino hydroxybenzoyl hexyl benzoate


Advanced Ingredient Data


Raw Label Data

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