Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID acfa1308-d9e5-4cbf-bacc-3e9779e6f94c
Route
CUTANEOUS
Published
Effective Date 2011-09-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.75 g) Zinc Cation (2.45 g) Titanium (1.45 g)
Inactive Ingredients
Water Cyclomethicone 5 Glycerin Dimethicone Aluminum Hydroxide Stearic Acid Methylparaben Phenoxyethanol Kiwi Fruit Propylparaben Caffeine Squalane Palmitoyl Tripeptide-5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-03-01
Description

Active ingredients: OCTINOXATE 7.5%, ZINC OXIDE 4.90%, TITANIUM DIOXIDE 2.90%

Medication Information

Warnings and Precautions

Warnings:

For external use only. Avoid contact with eyes.

Discontinue use if signs of irritation appear.

Indications and Usage

Indication and usage:

At the end of basic cosmetic care, apply in an adequate amount to body parts sensitive to UV radiation such as face, arms and legs, avoiding the eye area.

Dosage and Administration

Dosage and administration:

Apply about 15 to 20 minutes before going out.

Reapply as often as possible for a long-term outing or activities.

Description

Active ingredients: OCTINOXATE 7.5%, ZINC OXIDE 4.90%, TITANIUM DIOXIDE 2.90%

Section 50565-1

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6

Inactive ingredients:

Water, Cyclopentasiloxane, Ethylhexyl Salicylate, Glycerin, PEG-10 Dimethicone, Dimethicone, Dipropylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Magnesium Sulfate, Disteardimonium Hectorite, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Isoamyl p-Methoxycinnamate, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Stearic Acid, Methyl Methacrylate Crosspolymer, Methylparaben, Phenoxyethanol, Fragrance(Parfum), Actinidia Chinensis (Kiwi) Fruit Extract, Propylparaben, Caffeine, Sea Water, Polydecene, Squalane, Viscum Album (Mistletoe) Extract, Palmitoyl Tripeptide-5

Section 51945-4

Section 55105-1

Purpose: Protects skin from UV rays.

Section 55106-9

Active ingredients: OCTINOXATE 7.5%, ZINC OXIDE 4.90%, TITANIUM DIOXIDE 2.90%

Structured Label Content

Indications and Usage (34067-9)

Indication and usage:

At the end of basic cosmetic care, apply in an adequate amount to body parts sensitive to UV radiation such as face, arms and legs, avoiding the eye area.

Dosage and Administration (34068-7)

Dosage and administration:

Apply about 15 to 20 minutes before going out.

Reapply as often as possible for a long-term outing or activities.

Warnings and Precautions (34071-1)

Warnings:

For external use only. Avoid contact with eyes.

Discontinue use if signs of irritation appear.

Section 50565-1 (50565-1)

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients:

Water, Cyclopentasiloxane, Ethylhexyl Salicylate, Glycerin, PEG-10 Dimethicone, Dimethicone, Dipropylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Magnesium Sulfate, Disteardimonium Hectorite, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Isoamyl p-Methoxycinnamate, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Stearic Acid, Methyl Methacrylate Crosspolymer, Methylparaben, Phenoxyethanol, Fragrance(Parfum), Actinidia Chinensis (Kiwi) Fruit Extract, Propylparaben, Caffeine, Sea Water, Polydecene, Squalane, Viscum Album (Mistletoe) Extract, Palmitoyl Tripeptide-5

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Protects skin from UV rays.

Section 55106-9 (55106-9)

Active ingredients: OCTINOXATE 7.5%, ZINC OXIDE 4.90%, TITANIUM DIOXIDE 2.90%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:20.351974 · Updated: 2026-03-14T22:52:50.897919