Ray Defense Spf 30

Ray Defense Spf 30
SPL v4
SPL
SPL Set ID 5af44d4c-898a-4622-8c46-9676cd9124fb
Route
TOPICAL
Published
Effective Date 2012-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.0 mL) Octinoxate (7.5 mL) Octisalate (5.0 mL) Octocrylene Oxybenzone
Inactive Ingredients
Allantoin Aloe Vera Leaf Alkyl (c12-15) Benzoate Green Tea Leaf Medium-chain Triglycerides Cetyl Alcohol Chamomile Citrus Aurantium Flower Oil Citrus Reticulata Leaf Oil Cyclomethicone 5 Dimethicone Dimethiconol (41 Mpa.s) Ethylhexylglycerin Glycerin Glyceryl Monostearate Glycol Distearate Isohexadecane Lavender Oil Peg-100 Stearate Polysorbate 80 Potassium Cetyl Phosphate Sage Oil Clary Sage Oil Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Sodium Hydroxide Stearyl Alcohol Edetate Sodium Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-03-23

Description

Active ingredients               Purpose Avobenzone 2.0 %              Sunscreen Octinoxate 7.5 %                Sunscreen Octisalate 5.0 %                 Sunscreen Octocrylene 7.5 %               Sunscreen Oxybenzone 5.0%                Sunscreen


Medication Information

Warnings and Precautions

Warnings



For external Use only

Do not use on broken skin.

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

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

Directions

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

children under 6 months: Ask a doctor

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 or higher and other sun protection measures including:

limit time in the sun, especially from 10 a.m. - 2 p.m.

Wear long-sleeve shirts, pants, hats, and sunglasses

Description

Active ingredients               Purpose Avobenzone 2.0 %              Sunscreen Octinoxate 7.5 %                Sunscreen Octisalate 5.0 %                 Sunscreen Octocrylene 7.5 %               Sunscreen Oxybenzone 5.0%                Sunscreen

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Extract, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Carbomer, Cetyl alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium (Bitter Orange) Flower Oil, Citrus Reticulata (Tangerine) Leaf Oil, Cyclopentasiloxane, Dimethicone, Dimethiconol, Ehtylhexylglycerin, Glycerin, Glyceryl Stearate, Glycol Distearate, Isohexadecane, Lavandula Angustifolia (Lavender) Oil, PEG-100 Stearate, Polysorbate 80, Potassium Cetyl Phophate, Salvia Officinalis (Sage) Oil, Salvea Sclarea (Clary Oil), Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Hydroxide, Stearyl Alcohol, Tetrasodium EDTA,Titanium Dioxide, Tocopheryl Acetate, Water (Aqua, Eau)





Section 51945-4

Bioelements

Ray Defense SPF 30



Broad Spectrum SPF 30 Sunscreen



Moisturizes and decreases the risk of early skin aging caused by the sun when used as directed.



118 mL / 4 Fl.Oz.









Section 55105-1

Uses

Helps prevent sunburn

If used as directed with other sun protection measure (see Direction) decreases the risk of skin cancer and early skin aging caused by the sun.

Section 55106-9

Active ingredients               Purpose

Avobenzone 2.0 %              Sunscreen

Octinoxate 7.5 %                Sunscreen

Octisalate 5.0 %                 Sunscreen

Octocrylene 7.5 %               Sunscreen

Oxybenzone 5.0%                Sunscreen




Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

Directions

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

children under 6 months: Ask a doctor

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 or higher and other sun protection measures including:

limit time in the sun, especially from 10 a.m. - 2 p.m.

Wear long-sleeve shirts, pants, hats, and sunglasses

Warnings and Precautions (34071-1)

Warnings



For external Use only

Do not use on broken skin.

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Extract, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Carbomer, Cetyl alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium (Bitter Orange) Flower Oil, Citrus Reticulata (Tangerine) Leaf Oil, Cyclopentasiloxane, Dimethicone, Dimethiconol, Ehtylhexylglycerin, Glycerin, Glyceryl Stearate, Glycol Distearate, Isohexadecane, Lavandula Angustifolia (Lavender) Oil, PEG-100 Stearate, Polysorbate 80, Potassium Cetyl Phophate, Salvia Officinalis (Sage) Oil, Salvea Sclarea (Clary Oil), Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Hydroxide, Stearyl Alcohol, Tetrasodium EDTA,Titanium Dioxide, Tocopheryl Acetate, Water (Aqua, Eau)





Section 51945-4 (51945-4)

Bioelements

Ray Defense SPF 30



Broad Spectrum SPF 30 Sunscreen



Moisturizes and decreases the risk of early skin aging caused by the sun when used as directed.



118 mL / 4 Fl.Oz.









Section 55105-1 (55105-1)

Uses

Helps prevent sunburn

If used as directed with other sun protection measure (see Direction) decreases the risk of skin cancer and early skin aging caused by the sun.

Section 55106-9 (55106-9)

Active ingredients               Purpose

Avobenzone 2.0 %              Sunscreen

Octinoxate 7.5 %                Sunscreen

Octisalate 5.0 %                 Sunscreen

Octocrylene 7.5 %               Sunscreen

Oxybenzone 5.0%                Sunscreen




Advanced Ingredient Data


Raw Label Data

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