Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ff32ffa8-f320-45b8-b514-6710f4972752
Route
CUTANEOUS
Published
Effective Date 2011-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (1.47 g) Zinc Cation (1.03 g) Titanium (0.87 g)
Inactive Ingredients
Dimethicone Triethylhexanoin Silicon Dioxide Talc Phenyl Trimethicone Ceresin Aluminum Hydroxide Stearic Acid Triethoxycaprylylsilane Glyceryl Caprylate Caprylyl Glycol Kiwi Fruit Argan Oil Sunflower Oil

Identifiers & Packaging

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

Active ingredients: OCTINOXATE 7%, ZINC OXIDE 4.9%, TITANIUM DIOXIDE 4.15%

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%, ZINC OXIDE 4.9%, TITANIUM DIOXIDE 4.15%

Section 50565-1

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6

Inactive ingredients:

Dimethicone, Triethylhexanoin, Silica, Talc, Phenyl Trimethicone, Isoamyl p-Methoxycinnamate, Polyethylene, Ceresin, Sorbitan Isostearate, Microcrystalline Wax, Vinyl Dimethicone/Methicone Silsesquiox ane Crosspolymer, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Fragrance(Parfum), Polyglyceryl-2 Triisostearate, Iron Oxides (CI 77492), Glyceryl Caprylate, Caprylyl Glycol, Iron Oxides (CI 77491), Actinidia Chinensis (Kiwi) Fruit Extract, Argania Spinosa Kernel Oil, Hydroxyapatite, Helianthus Annuus (Sunflower) Seed Oil

Section 51945-4

Section 55105-1

Purpose: Protects skin from UV rays.

Section 55106-9

Active ingredients: OCTINOXATE 7%, ZINC OXIDE 4.9%, TITANIUM DIOXIDE 4.15%

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:

Dimethicone, Triethylhexanoin, Silica, Talc, Phenyl Trimethicone, Isoamyl p-Methoxycinnamate, Polyethylene, Ceresin, Sorbitan Isostearate, Microcrystalline Wax, Vinyl Dimethicone/Methicone Silsesquiox ane Crosspolymer, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Fragrance(Parfum), Polyglyceryl-2 Triisostearate, Iron Oxides (CI 77492), Glyceryl Caprylate, Caprylyl Glycol, Iron Oxides (CI 77491), Actinidia Chinensis (Kiwi) Fruit Extract, Argania Spinosa Kernel Oil, Hydroxyapatite, Helianthus Annuus (Sunflower) Seed Oil

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%, ZINC OXIDE 4.9%, TITANIUM DIOXIDE 4.15%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:21.042412 · Updated: 2026-03-14T22:52:53.430326