29cc6b6a-f476-1234-e054-00144ff88e88

SPL v3
SPL
SPL Set ID 29cc6b6a-f476-1234-e054-00144ff88e88
Route
topical
Published
Effective Date 2016-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (20557.8 mg) octocrylene (4725 mg)
Inactive Ingredients
bemotrizinol caprylyl trisiloxane edetate disodium aloe vera leaf portulaca oleracea whole chinese cinnamon nymphaea alba flower oregano willow bark platinum neopentyl glycol diheptanoate glyceryl caprylate butylene glycol ethylhexyl palmitate stearic acid aluminum hydroxide disteardimonium hectorite caprylyl glycol water phenoxyethanol 1,2-hexanediol ethylhexylglycerin cyclomethicone 5 alcohol prunus mume fruit chamaecyparis obtusa leaf scutellaria baicalensis root

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2016-01-14

Purpose

Skin Protectant

Description

Ethylhexyl Methoxycinnamate 7.30%, Octocrylene 3.00%, Titanium Dioxide 3.24%, Zinc Oxide 4.32%


Medication Information

Purpose

Skin Protectant

Directions

After fully shaking the bottle, spray for 2-3 seconds from a distance of 20 cm on skin areas exposed to UV rays.

Inactive Ingredients

Water, Cyclopentasiloxane, Cyclohexasiloxane, Alcohol Denat., Butylene Glycol, Methyl Methacrylate Crosspolymer, Ethylhexyl Palmitate, PEG-10 Dimethicone, Silica, Neopentyl Glycol Diheptanoate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Caprylyl Methicone, Aluminum Hydroxide, Glyceryl Caprylate, Stearic Acid, Disteardimonium Hectorite, Fragrance(Parfum), Dimethicone/Methicone Copolymer, Caprylyl Glycol, Disodium EDTA, Water, Phenoxyethanol, Prunus Mume Fruit Water, Nymphaea Alba Flower Extract, Aloe Barbadensis Leaf Extract, 1,2-Hexanediol, Origanum Vulgare Leaf Extract, Salix Alba (Willow) Bark Extract, Chamaecyparis Obtusa Leaf Extract, Ethylhexylglycerin, Portulaca Oleracea Extract, Cinnamomum Cassia Bark Extract, Scutellaria Baicalensis Root Extract, Lactobacillus/Soybean Ferment Extract, Polymethylsilsesquioxane, Platinum Powder

Description

Ethylhexyl Methoxycinnamate 7.30%, Octocrylene 3.00%, Titanium Dioxide 3.24%, Zinc Oxide 4.32%

Principal Display Panel

Use

Sunscreen

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.

Active Ingredients

Ethylhexyl Methoxycinnamate 7.30%, Octocrylene 3.00%, Titanium Dioxide 3.24%, Zinc Oxide 4.32%

Keep Out of Reach of Children

Keep out of reach of children.


Structured Label Content

Purpose

Skin Protectant

Directions

After fully shaking the bottle, spray for 2-3 seconds from a distance of 20 cm on skin areas exposed to UV rays.

Inactive Ingredients

Water, Cyclopentasiloxane, Cyclohexasiloxane, Alcohol Denat., Butylene Glycol, Methyl Methacrylate Crosspolymer, Ethylhexyl Palmitate, PEG-10 Dimethicone, Silica, Neopentyl Glycol Diheptanoate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Caprylyl Methicone, Aluminum Hydroxide, Glyceryl Caprylate, Stearic Acid, Disteardimonium Hectorite, Fragrance(Parfum), Dimethicone/Methicone Copolymer, Caprylyl Glycol, Disodium EDTA, Water, Phenoxyethanol, Prunus Mume Fruit Water, Nymphaea Alba Flower Extract, Aloe Barbadensis Leaf Extract, 1,2-Hexanediol, Origanum Vulgare Leaf Extract, Salix Alba (Willow) Bark Extract, Chamaecyparis Obtusa Leaf Extract, Ethylhexylglycerin, Portulaca Oleracea Extract, Cinnamomum Cassia Bark Extract, Scutellaria Baicalensis Root Extract, Lactobacillus/Soybean Ferment Extract, Polymethylsilsesquioxane, Platinum Powder

Principal Display Panel

Use

Sunscreen

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.

Active Ingredients

Ethylhexyl Methoxycinnamate 7.30%, Octocrylene 3.00%, Titanium Dioxide 3.24%, Zinc Oxide 4.32%

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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