Ray Defense - Broad Spectrum Spf 30 Sunscreen

Ray Defense - Broad Spectrum Spf 30 Sunscreen
SPL v11
SPL
SPL Set ID 807db1ff-a64a-44e4-a786-f88cd4518433
Route
TOPICAL
Published
Effective Date 2015-12-29
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 Alkyl (c12-15) Benzoate Camellia Oleifera Leaf Medium-chain Triglycerides Carbomer 940 Cetyl Alcohol Chamomile Citrus Aurantium Flower Oil Citrus Reticulata Leaf Oil Cyclomethicone 5 Dimethicone Ethylhexylglycerin Glycerin Glyceryl Stearate Se Glycol Distearate Isohexadecane Lavender Oil Lavandin Oil Peg-100 Stearate Polysorbate 80 Potassium Cetyl Phosphate Phenoxyethanol 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 DRUG Active Since 2015-04-27

Description

Active Ingredients           Purpose 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

- For external use only

- Do not use on damaged or broken skin

-  When using this productkeep out of eyes. Rinse with water to remove.

Indications and Usage

Stop use and ask a doctorif rash occurs

Dosage and Administration
  • Apply liberally 15 minutes before sun exposure
  • Use a water resistan 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 7.0% ......... 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

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Extract, C12-15 Alkyl Benzoate, Camellia Oleifera Leaf Extract, Caprylic/Capric Triglyceride, Carbomer, Cetyl Alcoho, Cahmomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Citrus Reticulata (Tangerine) Leaf Oil, Cyclopentasiloxane Dimethicone, Dimethiconol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycol Distearate, Isohexadecane, Lavandula Angustifolia (Lavender) Oil, Lavandula Hybrida Oil, PEG-100 Stearate, Polysorbate 80, Potassium Cetyl Phosphate, Phenoxyethanol, 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

Ray Defense

Broad Spectrum

SPF 30 Sunscreen

59 mL. / 2 Fl. OZ

Section 55105-1
  • 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           Purpose

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 doctorif rash occurs

Dosage and Administration (34068-7)
  • Apply liberally 15 minutes before sun exposure
  • Use a water resistan 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)

- For external use only

- Do not use on damaged or broken skin

-  When using this productkeep 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)

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Extract, C12-15 Alkyl Benzoate, Camellia Oleifera Leaf Extract, Caprylic/Capric Triglyceride, Carbomer, Cetyl Alcoho, Cahmomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Citrus Reticulata (Tangerine) Leaf Oil, Cyclopentasiloxane Dimethicone, Dimethiconol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycol Distearate, Isohexadecane, Lavandula Angustifolia (Lavender) Oil, Lavandula Hybrida Oil, PEG-100 Stearate, Polysorbate 80, Potassium Cetyl Phosphate, Phenoxyethanol, 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)

Ray Defense

Broad Spectrum

SPF 30 Sunscreen

59 mL. / 2 Fl. OZ

Section 55105-1 (55105-1)
  • 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           Purpose

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

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