SPL v1
SPL
SPL Set ID 4ad83e74-b8fc-430d-abf9-01f8c09f1337
Route
TOPICAL
Published
Effective Date 2017-07-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.75 g) Octisalate (2.5 g) Zinc Cation (2.45 g) Titanium Dioxide (1.45 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-03-08

Description

Active ingredients: Ethylhexyl Methoxycinnamate 7.5%, Ethylhexyl Salicylate 5.0%, Zinc Oxide 4.9%, Titanium Dioxide 2.9%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Uses: Apply an appropriate amount to your face then apply it along the skin texture, thin and wide, finish with massage.

Directions: in the morning, as the last step in your basic routine, lightly apply a desired amount to your entire face.

Warnings

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use.

Keep Out of Reach of Children: Do not use on hurt or abraded skin.

Active Ingredient

Active ingredients: Ethylhexyl Methoxycinnamate 7.5%, Ethylhexyl Salicylate 5.0%, Zinc Oxide 4.9%, Titanium Dioxide 2.9%

Inactive Ingredient

Inactive ingredients: Water, Cyclopentasiloxane, Butylene Glycol, Dipropylene Glycol, Glycerin, PEG-10 Dimethicone, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Isoamyl p-Methoxycinnamate, Glyceryl Caprylate, Fragrance(Parfum), Aluminum Hydroxide, Stearic Acid, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Glycol, Ecklonia Cava Extract, Panax Ginseng Root Extract, Saccharide Isomerate, Ginsenosides, Camellia Sinensis Leaf Extract, Honey Extract, Portulaca Oleracea Extract, Cinnamomum Cassia Bark Extract, Chaenomeles Sinensis Fruit Extract, Citrus Aurantifolia (Lime) Fruit Extract, Chrysanthemum Indicum Flower Extract, Phenoxyethanol, Cnidium Officinale Root Extract, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use.

Keep Out of Reach of Children: Do not use on hurt or abraded skin.

Description (DESCRIPTION)

Uses: Apply an appropriate amount to your face then apply it along the skin texture, thin and wide, finish with massage.

Directions: in the morning, as the last step in your basic routine, lightly apply a desired amount to your entire face.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Ethylhexyl Methoxycinnamate 7.5%, Ethylhexyl Salicylate 5.0%, Zinc Oxide 4.9%, Titanium Dioxide 2.9%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Water, Cyclopentasiloxane, Butylene Glycol, Dipropylene Glycol, Glycerin, PEG-10 Dimethicone, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Isoamyl p-Methoxycinnamate, Glyceryl Caprylate, Fragrance(Parfum), Aluminum Hydroxide, Stearic Acid, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Glycol, Ecklonia Cava Extract, Panax Ginseng Root Extract, Saccharide Isomerate, Ginsenosides, Camellia Sinensis Leaf Extract, Honey Extract, Portulaca Oleracea Extract, Cinnamomum Cassia Bark Extract, Chaenomeles Sinensis Fruit Extract, Citrus Aurantifolia (Lime) Fruit Extract, Chrysanthemum Indicum Flower Extract, Phenoxyethanol, Cnidium Officinale Root Extract, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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