Ray Defense Spf 30

Ray Defense Spf 30
SPL v1
SPL
SPL Set ID d333a58e-742b-488e-bf69-0e3df93ce304
Route
TOPICAL
Published
Effective Date 2013-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2 g) Octinoxate (7.5 g) Octisalate (5 g) Octocrylene (7 g) Oxybenzone
Inactive Ingredients
Allantoin Aloe Vera Leaf C12-15 Alkyl Benzoate Green Tea Leaf Medium-chain Triglycerides Carbomer 934 Cetyl Alcohol Chamomile Citrus Aurantium Flower Oil Citrus Reticulata Leaf Oil Cyclomethicone 5 Dimethicone Dimethiconol (40 Cst) 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 .alpha.-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-07-11

Description

Active ingredients            Sunscreen Avobenzone 2.0%            Sunscreen Octinoxate  7.5%             Sunscreen Octisalate 5.0%               Sunscreen  Octocrylene 7.0%            Sunscreen Oxybenzone 5.0%           Sunscreen 


Medication Information

Warnings and Precautions

Warnings

· 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.

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

Directions 

· Apply liberally 15 minutes before sun exposure

· Reapply at least every 2 hours

· Use a water resistant sunscreen if swimming or sweating

· 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 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            Sunscreen Avobenzone 2.0%            Sunscreen Octinoxate  7.5%             Sunscreen Octisalate 5.0%               Sunscreen  Octocrylene 7.0%            Sunscreen Oxybenzone 5.0%           Sunscreen 

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or

contact a Poison Control Center right away.

Section 51727-6

Allantoin, Aloe Barbdadenesis 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, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycol Distearate Isohexadecane, Lavandula Angustifolia (Lavender) Oil, PEG-100 Stearate, Polysorbate 80, Potassium Cetyl Phosphate, Salvia Officinalis (Sage) Oil, Salvia 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 Broad Spectrum SPF 30 Sunscreen

Hydrating moisturizer to protect skin

Decreases the risk of Skin Cancer and early skin aging caused by the sun when used as directed

Section 55105-1

Uses

· helps prevent sunburn

· If used as directed with other sun protection measures (see Directions),

decreases the risk of skin cancer and early skin aging caused by the sun

Section 55106-9

Active ingredients            Sunscreen

Avobenzone 2.0%            Sunscreen

Octinoxate  7.5%             Sunscreen

Octisalate 5.0%               Sunscreen 

Octocrylene 7.0%            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

· Reapply at least every 2 hours

· Use a water resistant sunscreen if swimming or sweating

· 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 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 damaged or 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 product is swallowed, get medical help or

contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Allantoin, Aloe Barbdadenesis 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, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycol Distearate Isohexadecane, Lavandula Angustifolia (Lavender) Oil, PEG-100 Stearate, Polysorbate 80, Potassium Cetyl Phosphate, Salvia Officinalis (Sage) Oil, Salvia 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 Broad Spectrum SPF 30 Sunscreen

Hydrating moisturizer to protect skin

Decreases the risk of Skin Cancer and early skin aging caused by the sun when used as directed

Section 55105-1 (55105-1)

Uses

· helps prevent sunburn

· If used as directed with other sun protection measures (see Directions),

decreases the risk of skin cancer and early skin aging caused by the sun

Section 55106-9 (55106-9)

Active ingredients            Sunscreen

Avobenzone 2.0%            Sunscreen

Octinoxate  7.5%             Sunscreen

Octisalate 5.0%               Sunscreen 

Octocrylene 7.0%            Sunscreen

Oxybenzone 5.0%           Sunscreen 


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)