SPL v1
SPL
SPL Set ID b2518a5b-af1b-4604-93e3-7f2fbd21cf68
Route
TOPICAL
Published
Effective Date 2019-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (1.70 g) Octinoxate (1.05 g) Octisalate (0.45 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-03-01

Description

Active ingredients: Titanium Dioxide 11.38%, Ethylhexyl Methoxycinnamate 7.00%, Ethylhexyl Salicylate 3.00%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Uses:

Helps prevent sunburn.

Directions:

1) Use at the sunscreen step after your basic skin care routine (it works as a sunblock, makeup base, and foundation) or Make-up before and after can be used.

2) Using the puff applicator, press down on the cushion sponge to get the foundation on the puff.

3) Close the inner lid tightly after each use to preserve freshness. Not closing the lid may cause the beneficial ingredients to evaporate and make the cushion sponge to shrink.

Warnings

Warnings:



For external use only

1) It is recommend to stop using the product and talk to dermatologist immediately if you are suffering such conditions : rash, swell up, itchiness.

2) Do not apply this product on any skin trouble.

3) Caution for storage and handling; always recap after use. Keep this product out of the reach of children. Avoid extremely high and low temperature and direct sunlight.

4) For the cleanliness in using the product, do not share the puff with someone else and it is recommended to keep it clean.

Active Ingredient

Active ingredients: Titanium Dioxide 11.38%, Ethylhexyl Methoxycinnamate 7.00%, Ethylhexyl Salicylate 3.00%

Inactive Ingredient

Inactive ingredients:

Water, Cyclopentasiloxane, Cyclohexasiloxane, Butylene Glycol, Diphenylsiloxy Phenyl Trimethicone, Isoamyl p-Methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, C12-15 Alkyl Benzoate, Niacinamide, Dicaprylyl Carbonate, Alcohol Denat., Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Trimethylsiloxysilicate, Sodium Chloride, Iron Oxides (CI 77492), Sorbitan Sesquioleate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Beeswax, Disteardimonium Hectorite, Polypropylsilsesquioxane, Isododecane, Dimethicone, Iron Oxides (CI 77491), Dipropylene Glycol, Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Chlorphenesin, Trihydroxystearin, 1,2-Hexanediol, Hydroxyacetophenone, Saccharum Officinarum (Sugar Cane) Extract, Sodium Hyaluronate, Mentha Rotundifolia Leaf Extract, Propylene Carbonate, Iron Oxides (CI 77499), Fragrance(Parfum), Dimethiconol, Adenosine, Triethoxycaprylylsilane, Disodium EDTA, Brassica Campestris (Rapeseed) Flower Extract, Narcissus Tazetta Extract, Calendula Officinalis Flower Extract, Freesia Alba Flower Extract, Taraxacum Officinale (Dandelion) Extract, Helianthus Annuus (Sunflower) Flower Extract, Oxalis Hedysaroides Extract, Papaver Rhoeas Flower Extract, Glycerin, Tocopherol

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings:



For external use only

1) It is recommend to stop using the product and talk to dermatologist immediately if you are suffering such conditions : rash, swell up, itchiness.

2) Do not apply this product on any skin trouble.

3) Caution for storage and handling; always recap after use. Keep this product out of the reach of children. Avoid extremely high and low temperature and direct sunlight.

4) For the cleanliness in using the product, do not share the puff with someone else and it is recommended to keep it clean.

Description (DESCRIPTION)

Uses:

Helps prevent sunburn.

Directions:

1) Use at the sunscreen step after your basic skin care routine (it works as a sunblock, makeup base, and foundation) or Make-up before and after can be used.

2) Using the puff applicator, press down on the cushion sponge to get the foundation on the puff.

3) Close the inner lid tightly after each use to preserve freshness. Not closing the lid may cause the beneficial ingredients to evaporate and make the cushion sponge to shrink.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Titanium Dioxide 11.38%, Ethylhexyl Methoxycinnamate 7.00%, Ethylhexyl Salicylate 3.00%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients:

Water, Cyclopentasiloxane, Cyclohexasiloxane, Butylene Glycol, Diphenylsiloxy Phenyl Trimethicone, Isoamyl p-Methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, C12-15 Alkyl Benzoate, Niacinamide, Dicaprylyl Carbonate, Alcohol Denat., Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Trimethylsiloxysilicate, Sodium Chloride, Iron Oxides (CI 77492), Sorbitan Sesquioleate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Beeswax, Disteardimonium Hectorite, Polypropylsilsesquioxane, Isododecane, Dimethicone, Iron Oxides (CI 77491), Dipropylene Glycol, Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Chlorphenesin, Trihydroxystearin, 1,2-Hexanediol, Hydroxyacetophenone, Saccharum Officinarum (Sugar Cane) Extract, Sodium Hyaluronate, Mentha Rotundifolia Leaf Extract, Propylene Carbonate, Iron Oxides (CI 77499), Fragrance(Parfum), Dimethiconol, Adenosine, Triethoxycaprylylsilane, Disodium EDTA, Brassica Campestris (Rapeseed) Flower Extract, Narcissus Tazetta Extract, Calendula Officinalis Flower Extract, Freesia Alba Flower Extract, Taraxacum Officinale (Dandelion) Extract, Helianthus Annuus (Sunflower) Flower Extract, Oxalis Hedysaroides Extract, Papaver Rhoeas Flower Extract, Glycerin, Tocopherol

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


Advanced Ingredient Data


Raw Label Data

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