Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID fc90fb8a-44b3-47cd-882e-94ed324ed389
Route
TOPICAL
Published
Effective Date 2018-11-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (2.1 mg) Octisalate (0.9 mg) Titanium Dioxide (2.5215 mg)
Inactive Ingredients
Water Alkyl (c12-15) Benzoate Cyclomethicone 5 Cyclomethicone Butylene Glycol Amiloxate Cyclomethicone 6 Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Niacinamide Dicaprylyl Carbonate Bemotrizinol Ceresin Ferric Oxide Yellow Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Diisostearyl Malate Sodium Chloride Mica Disteardimonium Hectorite Sorbitan Sesquioleate Synthetic Wax (1200 Mw) Sorbitan Olivate Silicon Dioxide Ferric Oxide Red Ferrosoferric Oxide Silica Dimethyl Silylate Chlorphenesin Dipropylene Glycol Dimethicone Propylene Carbonate 1,2-hexanediol Hydroxyacetophenone Bergamot Oil Orange Oil Cananga Oil Adenosine Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-11-27

Description

Titanium Dioxide 8.41% Ethylhexyl Methoxycinnamate 7.00% Ethylhexyl Salicylate 3.00%


Medication Information

Warnings and Precautions

For external use only.

Do not use on damaged or broken skin.

When using this product, keep out of eyes. Rinse with water to remove.

Stop using and ask a doctor if rash occurs.

Indications and Usage

Helps prevent sunburn

Dosage and Administration

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

Ask a doctor to use for children under 6 months

Description

Titanium Dioxide 8.41% Ethylhexyl Methoxycinnamate 7.00% Ethylhexyl Salicylate 3.00%

Section 50565-1

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Section 51727-6

Water, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Cyclomethicone, Butylene Glycol, Isoamyl p-Methoxycinnamate, Cyclohexasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, Niacinamide, Dicaprylyl Carbonate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Ceresin, Iron Oxides (CI 77492), Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Diisostearyl Malate, Sodium Chloride, Mica (CI 77019), Disteardimonium Hectorite, Sorbitan Sesquioleate, Synthetic Wax, Sorbitan Olivate, Silica, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Polyester-1, Silica Dimethyl Silylate, Chlorphenesin, Dipropylene Glycol, Vegetable Oil, Dimethicone, Propylene Carbonate, 1,2-Hexanediol, Hydroxyacetophenone, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, Cananga Odorata Flower Oil, Adenosine, Disodium EDTA, Natto Gum, Saussurea Involucrata Extract, Bambusa Vulgaris Leaf/Stem Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Cocos Nucifera (Coconut) Oil, Tocopheryl Acetate, Hydrolyzed Hyaluronic Acid, Tocopherol

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Titanium Dioxide 8.41%

Ethylhexyl Methoxycinnamate 7.00%

Ethylhexyl Salicylate 3.00%


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

Ask a doctor to use for children under 6 months

Warnings and Precautions (34071-1)

For external use only.

Do not use on damaged or broken skin.

When using this product, keep out of eyes. Rinse with water to remove.

Stop using and ask a doctor if rash occurs.

Section 50565-1 (50565-1)

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Section 51727-6 (51727-6)

Water, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Cyclomethicone, Butylene Glycol, Isoamyl p-Methoxycinnamate, Cyclohexasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, Niacinamide, Dicaprylyl Carbonate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Ceresin, Iron Oxides (CI 77492), Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Diisostearyl Malate, Sodium Chloride, Mica (CI 77019), Disteardimonium Hectorite, Sorbitan Sesquioleate, Synthetic Wax, Sorbitan Olivate, Silica, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Polyester-1, Silica Dimethyl Silylate, Chlorphenesin, Dipropylene Glycol, Vegetable Oil, Dimethicone, Propylene Carbonate, 1,2-Hexanediol, Hydroxyacetophenone, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, Cananga Odorata Flower Oil, Adenosine, Disodium EDTA, Natto Gum, Saussurea Involucrata Extract, Bambusa Vulgaris Leaf/Stem Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Cocos Nucifera (Coconut) Oil, Tocopheryl Acetate, Hydrolyzed Hyaluronic Acid, Tocopherol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Titanium Dioxide 8.41%

Ethylhexyl Methoxycinnamate 7.00%

Ethylhexyl Salicylate 3.00%


Advanced Ingredient Data


Raw Label Data

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