SPL v1
SPL
SPL Set ID b444d3cf-4d44-6d08-e053-2a95a90ac6a1
Route
TOPICAL
Published
Effective Date 2020-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (4.455 g) Titanium Dioxide (6.24 g) Octinoxate (7.5 g) Octisalate (3 g)
Inactive Ingredients
Dimethicone Peg-10 Dimethicone (600 Cst) Sodium Chloride Sorbitan Sesquioleate Polyhydroxystearic Acid (2300 Mw) Frankincense Oil Isostearic Acid Hydrogen Dimethicone (13 Cst) Adenosine Silicon Dioxide Tripropylene Glycol Sodium Citrate Allantoin Tocopherol Arginine Butylene Glycol Glycerin 1,2-hexanediol Niacinamide Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Hydrogenated Poly(c6-14 Olefin; 2 Cst) Ceresin Disteardimonium Hectorite Barium Sulfate Aluminum Hydroxide Citric Acid Monohydrate Dimethicone/peg-10/15 Crosspolymer Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Lavender Oil Ethylhexyl Palmitate Isopropyl Myristate Lecithin, Soybean Propylene Glycol Alanine Histidine Leucine Magnesium Stearate Polyglyceryl-3 Pentaricinoleate Stearic Acid Magnesium Myristate Water Dipropylene Glycol Cyclomethicone 5 Cetyl Ethylhexanoate Methionine Portulaca Oleracea Leaf Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Tyrosine Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-11-17

Description

Ethylhexyl Methoxycinnamate 7.5%, Titanium Dioxide 6.24%, Zinc Oxide 4.455%, Ethylhexyl Salicylate3.0%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Apply with your skin before direct sunlight.

Dosage and Administration

Apply appropriate amount on your skin.

Description

Directions: 1. Apply after basic skin care product. 2. Spread an appropriate amount over the entire face following the skin texture. 3. Reapply as required.

Section 50565-1

Keep Out of Reach of Children.

Section 50566-9

Do not use on damaged or broken Skin. Stop use and ask a doctor if rash occurs.

Section 51727-6

Water, Cyclopentasiloxane, Dipropylene Glycol, Cetyl Ethylhexanoate, Butylene Glycol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Glycerin, 1,2-Hexanediol, Niacinamide, Methyl Methacrylate Crosspolymer, Dimethicone, Hydrogenated C6-14 Olefin Polymers, PEG-10 Dimethicone, Ozokerite, Sodium Chloride, Disteardimonium Hectorite, Barium Sulfate, Magnesium Stearate, Aluminum Hydroxide, Sorbitan Sesquioleate, Stearic Acid, Citric Acid, Dimethicone/PEG-10/15 Crosspolymer, Polysilicone-11, Polyhydroxystearic Acid, Lavandula Angustifolia (Lavender) Oil, Boswellia Carterii Oil, Ethylhexyl Palmitate, Isopropyl Myristate, Isostearic Acid, Lecithin, Hydrogen Dimethicone, Adenosine, Polyglyceryl-3 Polyricinoleate, Silica, Disodium EDTA, Magnesium Myristate, Propylene Glycol, Tripropylene Glycol, Sodium Citrate, Allantoin, Portulaca Oleracea Extract, Tocopherol, Alanine, Arginine, Histidine, Tyrosine, Leucine, Methionine

Section 51945-4

Section 55105-1

Purpose: Sunscreen

Section 55106-9

Ethylhexyl Methoxycinnamate 7.5%, Titanium Dioxide 6.24%, Zinc Oxide 4.455%, Ethylhexyl Salicylate3.0%


Structured Label Content

Indications and Usage (34067-9)

Apply with your skin before direct sunlight.

Dosage and Administration (34068-7)

Apply appropriate amount on your skin.

Warnings and Precautions (34071-1)

For external use only.

Description (34089-3)

Directions: 1. Apply after basic skin care product. 2. Spread an appropriate amount over the entire face following the skin texture. 3. Reapply as required.

Section 50565-1 (50565-1)

Keep Out of Reach of Children.

Section 50566-9 (50566-9)

Do not use on damaged or broken Skin. Stop use and ask a doctor if rash occurs.

Section 51727-6 (51727-6)

Water, Cyclopentasiloxane, Dipropylene Glycol, Cetyl Ethylhexanoate, Butylene Glycol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Glycerin, 1,2-Hexanediol, Niacinamide, Methyl Methacrylate Crosspolymer, Dimethicone, Hydrogenated C6-14 Olefin Polymers, PEG-10 Dimethicone, Ozokerite, Sodium Chloride, Disteardimonium Hectorite, Barium Sulfate, Magnesium Stearate, Aluminum Hydroxide, Sorbitan Sesquioleate, Stearic Acid, Citric Acid, Dimethicone/PEG-10/15 Crosspolymer, Polysilicone-11, Polyhydroxystearic Acid, Lavandula Angustifolia (Lavender) Oil, Boswellia Carterii Oil, Ethylhexyl Palmitate, Isopropyl Myristate, Isostearic Acid, Lecithin, Hydrogen Dimethicone, Adenosine, Polyglyceryl-3 Polyricinoleate, Silica, Disodium EDTA, Magnesium Myristate, Propylene Glycol, Tripropylene Glycol, Sodium Citrate, Allantoin, Portulaca Oleracea Extract, Tocopherol, Alanine, Arginine, Histidine, Tyrosine, Leucine, Methionine

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 55106-9 (55106-9)

Ethylhexyl Methoxycinnamate 7.5%, Titanium Dioxide 6.24%, Zinc Oxide 4.455%, Ethylhexyl Salicylate3.0%


Advanced Ingredient Data


Raw Label Data

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