Oars & Alps Spf 50 100% Mineral Antioxidant Sunscreen Spray

Oars & Alps Spf 50 100% Mineral Antioxidant Sunscreen Spray
SPL v2
SPL
SPL Set ID f3971b85-a13e-4195-e053-2995a90a73cb
Route
TOPICAL
Published
Effective Date 2022-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (15.7 g) Titanium Dioxide (3.4 g)
Inactive Ingredients
Glycerin Sclerocarya Birrea Seed Oil Bentonite Caprylyl Glycol Isononyl Isononanoate Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Silicon Dioxide Dicaprylyl Carbonate Methyl Dihydroabietate Polyhydroxystearic Acid (2300 Mw) Sodium Stearoyl Glutamate Water Cladonia Rangiferina Whole C18-c21 Alkane Caprylhydroxamic Acid Cetostearyl Alcohol Tocopherol Coco Glucoside Aloe Vera Leaf Aluminum Oxide Butyloctyl Salicylate Propanediol Microcrystalline Cellulose Carboxymethylcellulose Sodium, Unspecified Levomenol Citric Acid Monohydrate Isocetyl Stearoyl Stearate Sodium Gluconate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-01

Description

Titanium Dioxide - 3.4% Zinc Oxide - 15.7%


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 use and ask a doctor if rash occurs.
Description

Titanium Dioxide - 3.4% Zinc Oxide - 15.7%

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 50565-1

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

Section 51727-6

Aloe Barbadensis Leaf Juice, Alumina, Bentonite, Bisabolol, Butyloctyl Salicylate, C18-21 Alkane, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Citric Acid, Cladonia Stellaris Extract, Coco-Glucoside, Dicaprylyl Carbonate, Glycerin, Isocetyl Stearoyl Stearate, Isononyl Isononanoate, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyester-8, Polyhydroxystearic Acid, Propanediol, Sclerocarya Birrea Seed Oil, Silica, Sodium Gluconate, Sodium Stearoyl Glutamate, Tocopherol, Water

Section 51945-4

Section 53413-1
Section 55105-1

Sunscreen

Section 55106-9

Titanium Dioxide - 3.4%

Zinc Oxide - 15.7%

Section 60561-8
  • Protect the product in this container from excessive heat and direct sun
  • Avoid spraying on facbrics - may cause discoloration
Directions
  • Apply generously and evenly 15 minutes before sun exposure
  • Hold container 4-6 inches from the skin to apply
  • Do not spray directly onto the face. Spray onto hands and rub onto face. Do not inhale.
  • Do not apply in windy conditions.
  • Use in well ventilated area.
  • Reapply: After 80 minutes of swimming or sweating, immedately after towl drying, at least every 2 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 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.​
  • Children under six months: Ask a doctor.

Structured Label Content

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.

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 use and ask a doctor if rash occurs.
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)

Aloe Barbadensis Leaf Juice, Alumina, Bentonite, Bisabolol, Butyloctyl Salicylate, C18-21 Alkane, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Citric Acid, Cladonia Stellaris Extract, Coco-Glucoside, Dicaprylyl Carbonate, Glycerin, Isocetyl Stearoyl Stearate, Isononyl Isononanoate, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyester-8, Polyhydroxystearic Acid, Propanediol, Sclerocarya Birrea Seed Oil, Silica, Sodium Gluconate, Sodium Stearoyl Glutamate, Tocopherol, Water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)
Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Titanium Dioxide - 3.4%

Zinc Oxide - 15.7%

Section 60561-8 (60561-8)
  • Protect the product in this container from excessive heat and direct sun
  • Avoid spraying on facbrics - may cause discoloration
Directions
  • Apply generously and evenly 15 minutes before sun exposure
  • Hold container 4-6 inches from the skin to apply
  • Do not spray directly onto the face. Spray onto hands and rub onto face. Do not inhale.
  • Do not apply in windy conditions.
  • Use in well ventilated area.
  • Reapply: After 80 minutes of swimming or sweating, immedately after towl drying, at least every 2 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 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.​
  • Children under six months: Ask a doctor.

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