SPL v1
SPL
SPL Set ID bd378a67-e7af-43f7-9796-416ee0b05fa0
Route
TOPICAL
Published
Effective Date 2018-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (1.4 g) Octocrylene (1.0 g) Octisalate (0.9 g)
Inactive Ingredients
Butylene Glycol Octyldodecanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-11-01

Description

Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Octocrylene 5.0%, Ethylhexyl Salicylate 4.5%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Uses:

A clear aloe stick sun screen, easy to apply to curved area, works over and under make up for sun protection.

Directions:

-Turn the dial at the bottom of the container and push up roughly.

-Apply liberally to face and all over the body frequently after sun exposure.

-Product can be applied over and under the makeup.

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

Active Ingredient

Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Octocrylene 5.0%, Ethylhexyl Salicylate 4.5%

Inactive Ingredient

Inactive ingredients:

Butylene Glycol Dicaprylate/Dicaprate, Octyldodecanol, Butyloctyl Salicylate, Polyamide-8, Dibutyl Ethylhexanoyl Glutamide, Dibutyl Lauroyl Glutamide, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Fragrance, Ethylhexyl Methoxycrylene, BHT, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Caprylyl Glycol, Coccinia Indica Fruit Extract, Ethylhexylglycerin, Solanum Melongena (Eggplant)Fruit Extract,Amber owder, Curcuma longa (Tumeric)Root Extract, Ocimum Sanctum Leaf Extract, Corallina Officinalis Extract, Moringa Pterygosperma Seed Oil, Camellia Oleifera Seed Oil, Argania Spinosa Kernel Oil, Prunus Amygdalus Dulcis (Sweet Almond) oil, Limnanthes Alba (Meadowfoam) Seed Oil, Eucalyptus Globulus Leaf Oil, Macadamia Ternifolia Seed Oil, Olea Europaea (Olive) Husk Oil, Adansonia Digitata Seed Oil, Rosmariunus Officinalis (Rosemary) Leaf Oil, Ale Barbadensis Leaf Juice, Butylene Glycol, Camellia Japonica Flower Extract, Dipropylene Glycol, Xylitylglucoside, Sodium Palmitoyl Proline, Anhydroxylitol, Water, Nelumbo Nucifera Flower Extract, Uncaria Gambir extract, Sanguisorba Officinalis Root extract, Cinnamomum Zeylanicum Bark Extract, Pelargonium Graveolens Extract, xylitol, Nyphaea Alba Flower extract, 1,2-Hexanediol, Glucose

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

Description (DESCRIPTION)

Uses:

A clear aloe stick sun screen, easy to apply to curved area, works over and under make up for sun protection.

Directions:

-Turn the dial at the bottom of the container and push up roughly.

-Apply liberally to face and all over the body frequently after sun exposure.

-Product can be applied over and under the makeup.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Octocrylene 5.0%, Ethylhexyl Salicylate 4.5%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients:

Butylene Glycol Dicaprylate/Dicaprate, Octyldodecanol, Butyloctyl Salicylate, Polyamide-8, Dibutyl Ethylhexanoyl Glutamide, Dibutyl Lauroyl Glutamide, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Fragrance, Ethylhexyl Methoxycrylene, BHT, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Caprylyl Glycol, Coccinia Indica Fruit Extract, Ethylhexylglycerin, Solanum Melongena (Eggplant)Fruit Extract,Amber owder, Curcuma longa (Tumeric)Root Extract, Ocimum Sanctum Leaf Extract, Corallina Officinalis Extract, Moringa Pterygosperma Seed Oil, Camellia Oleifera Seed Oil, Argania Spinosa Kernel Oil, Prunus Amygdalus Dulcis (Sweet Almond) oil, Limnanthes Alba (Meadowfoam) Seed Oil, Eucalyptus Globulus Leaf Oil, Macadamia Ternifolia Seed Oil, Olea Europaea (Olive) Husk Oil, Adansonia Digitata Seed Oil, Rosmariunus Officinalis (Rosemary) Leaf Oil, Ale Barbadensis Leaf Juice, Butylene Glycol, Camellia Japonica Flower Extract, Dipropylene Glycol, Xylitylglucoside, Sodium Palmitoyl Proline, Anhydroxylitol, Water, Nelumbo Nucifera Flower Extract, Uncaria Gambir extract, Sanguisorba Officinalis Root extract, Cinnamomum Zeylanicum Bark Extract, Pelargonium Graveolens Extract, xylitol, Nyphaea Alba Flower extract, 1,2-Hexanediol, Glucose

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


Advanced Ingredient Data


Raw Label Data

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