SPL v3
SPL
SPL Set ID 29ddedc4-e8fc-4b41-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (6295 mg) Zinc Oxide (27489 mg)
Inactive Ingredients
Water Aluminum Hydroxide Methylparaben Glyceryl Caprylate Magnesium Sulfate Chlorphenesin Caffeine Disteardimonium Hectorite Stearic Acid Propylparaben Cyclomethicone 5 Octisalate Amiloxate Butylene Glycol Portulaca Oleracea Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-01-14

Description

Dimethicone 2.10%, Dipropylene Glycol 2.00%, Ethylhexyl Methoxycinnamate 7.50%, Glycerin 5.00%, Titanium Dioxide 2.90%, Zinc Oxide 4.90%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Dimethicone 2.10%, Dipropylene Glycol 2.00%, Ethylhexyl Methoxycinnamate 7.50%, Glycerin 5.00%, Titanium Dioxide 2.90%, Zinc Oxide 4.90%

Use

This sun cream protects the skin effectively and continuously from strong ultraviolet sunlight. It has a highly-effective waterproof function so it cannot be easily washed off by water, sweat, or sebum, thereby maintaining its effect for many hours. It can be used on the face and body.

Caution

For external use only. Avoid contact with eyes. Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

Directions

Take an appropriate amount, evenly apply to face and body anywhere to be exposed to UV rays. Use as the last step of basic skin care.

Active Ingredients

Dimethicone 2.10%, Dipropylene Glycol 2.00%, Ethylhexyl Methoxycinnamate 7.50%, Glycerin 5.00%, Titanium Dioxide 2.90%, Zinc Oxide 4.90%

Inactive Ingredients

Water, Cyclopentasiloxane, Ethylhexyl Salicylate, PEG-10 Dimethicone, Magnesium Sulfate, Disteardimonium Hectorite, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Isoamyl p-Methoxycinnamate, Aluminum Hydroxide, Stearic Acid, Methylparaben, Chlorphenesin, Fragrance(Parfum), Caffeine, Butylene Glycol, Propylparaben, Portulaca Oleracea Extract

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children.


Structured Label Content

Use

This sun cream protects the skin effectively and continuously from strong ultraviolet sunlight. It has a highly-effective waterproof function so it cannot be easily washed off by water, sweat, or sebum, thereby maintaining its effect for many hours. It can be used on the face and body.

Caution

For external use only. Avoid contact with eyes. Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

Purpose

Sunscreen

Directions

Take an appropriate amount, evenly apply to face and body anywhere to be exposed to UV rays. Use as the last step of basic skin care.

Active Ingredients

Dimethicone 2.10%, Dipropylene Glycol 2.00%, Ethylhexyl Methoxycinnamate 7.50%, Glycerin 5.00%, Titanium Dioxide 2.90%, Zinc Oxide 4.90%

Inactive Ingredients

Water, Cyclopentasiloxane, Ethylhexyl Salicylate, PEG-10 Dimethicone, Magnesium Sulfate, Disteardimonium Hectorite, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Isoamyl p-Methoxycinnamate, Aluminum Hydroxide, Stearic Acid, Methylparaben, Chlorphenesin, Fragrance(Parfum), Caffeine, Butylene Glycol, Propylparaben, Portulaca Oleracea Extract

Principal Display Panel

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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