Blue Lizard Kids Spf 50 Sunscreen

Blue Lizard Kids Spf 50 Sunscreen
SPL v7
SPL
SPL Set ID ba4ae906-48c0-8384-e053-2995a90afb91
Route
TOPICAL
Published
Effective Date 2023-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (111 mg) Titanium Dioxide (59.5 mg) Octisalate (55.5 mg)
Inactive Ingredients
Polyhydroxystearic Acid (2300 Mw) Cetyl Dimethicone 25 Isostearyl Isostearate Ethylhexylglycerin Polyglyceryl-4 Isostearate Phenoxyethanol Propanediol Water Sorbitan Monooleate Stearic Acid .alpha.-tocopherol Acetate Dimethicone Trimethylsiloxysilicate (m/q 0.8-1.0) Hexadecyl Povidone (4 Hexadecyl Branches/repeat) Phenylpropanol Diisopropyl Sebacate Polyurethane-35 (not More Than 500 Mpa.s At 40%) Butyloctyl Salicylate Medium-chain Triglycerides Yellow Wax Aluminum Oxide Aluminum Stearate Triethoxycaprylylsilane Caprylyl Glycol Arginine Methylpropanediol Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Alkyl (c12-15) Benzoate Edetate Disodium Hexyl Laurate Hydrogenated Castor Oil Methyl Glucose Dioleate Octyldodecyl Neopentanoate Peg-7 Hydrogenated Castor Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-09 Until 2023-12-31

Description

Octisalate 5% Titanium Dioxide 5.36% Zinc Oxide 10%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octisalate 5% Titanium Dioxide 5.36% Zinc Oxide 10%

Uses
  • Helps prevent sunburn and photodamage caused by UVA/UVB exposure
  • Higher SPF gives more sunburn protection
  • If used as directed with other sun protection measures (see Directions ), decreases the risks of skin cancer and early skin aging caused by the sun
Warnings

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

• Stop use and ask doctor if • Rash or irritation occurs

• Do not use • On damaged or broken skin • If allergic to any ingredient

• If swallowed, get medical help or contact a Poison Control Center

Directions

• Shake well prior to use

• Apply liberally to dry skin 15 minutes before sun exposure

• For topical use only

• 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 value 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-sleeved shirts, pants, hats, and sunglasses.

• Reapply to dry skin: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours

Questions?

Visit www.bluelizardsunscreen.com or call 800.877.8869

Crown Laboratories, Inc., Johnson City, TN 37604

Other Information
  • Protect the product in this container from excessive heat and direct sun
  • May stain some fabrics
Active Ingredients

Octisalate 5%

Titanium Dioxide 5.36%

Zinc Oxide 10%

Inactive Ingredients

Alumina, Aluminum Stearate, Beeswax, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Capylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Diisopropyl Sebacate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Hexyl Laurate, Hydrogenated Castor Oil, Isostearyl Isostearate, L-Arginine, Methyl Glucose Dioleate, Methylpropanediol, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Phenoxyethanol, Phenylpropanol, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polyurethane-35, Propanediol, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP Hexadecene Copolymer

Blue Lizard Kids 5oz Tube

BLUE LIZARD

AUSTRALIAN SUNSCREEN

50+

UVA/UVB PROTECTION

BROAD SPECTRUM SPF 50+

No. 1 pediatrician recommended mineral-based sunscreen brand

KIDS

mineral-based sunscreen

combining mineral and chemical UV protectors

Smart Cap TECHNOLOGY

CAP CHANGES COLOR IN HARMFUL UV LIGHT

WATER RESISTANT (80 MINUTES)

P11778.01


Structured Label Content

Uses
  • Helps prevent sunburn and photodamage caused by UVA/UVB exposure
  • Higher SPF gives more sunburn protection
  • If used as directed with other sun protection measures (see Directions ), decreases the risks of skin cancer and early skin aging caused by the sun
Purpose

Sunscreen

Warnings

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

• Stop use and ask doctor if • Rash or irritation occurs

• Do not use • On damaged or broken skin • If allergic to any ingredient

• If swallowed, get medical help or contact a Poison Control Center

Directions

• Shake well prior to use

• Apply liberally to dry skin 15 minutes before sun exposure

• For topical use only

• 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 value 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-sleeved shirts, pants, hats, and sunglasses.

• Reapply to dry skin: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours

Questions?

Visit www.bluelizardsunscreen.com or call 800.877.8869

Crown Laboratories, Inc., Johnson City, TN 37604

Other Information
  • Protect the product in this container from excessive heat and direct sun
  • May stain some fabrics
Active Ingredients

Octisalate 5%

Titanium Dioxide 5.36%

Zinc Oxide 10%

Inactive Ingredients

Alumina, Aluminum Stearate, Beeswax, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Capylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Diisopropyl Sebacate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Hexyl Laurate, Hydrogenated Castor Oil, Isostearyl Isostearate, L-Arginine, Methyl Glucose Dioleate, Methylpropanediol, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Phenoxyethanol, Phenylpropanol, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polyurethane-35, Propanediol, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP Hexadecene Copolymer

Blue Lizard Kids 5oz Tube

BLUE LIZARD

AUSTRALIAN SUNSCREEN

50+

UVA/UVB PROTECTION

BROAD SPECTRUM SPF 50+

No. 1 pediatrician recommended mineral-based sunscreen brand

KIDS

mineral-based sunscreen

combining mineral and chemical UV protectors

Smart Cap TECHNOLOGY

CAP CHANGES COLOR IN HARMFUL UV LIGHT

WATER RESISTANT (80 MINUTES)

P11778.01


Advanced Ingredient Data


Raw Label Data

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