Oars & Alps - Spf 50 Mineral Lotion

Oars & Alps - Spf 50 Mineral Lotion
SPL v2
SPL
SPL Set ID f395bc39-daa5-53b8-e053-2995a90a5f48
Route
TOPICAL
Published
Effective Date 2023-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (19.6 g)
Inactive Ingredients
Methyl Dihydroabietate Sodium Gluconate Carboxymethylcellulose Sodium, Unspecified Cetostearyl Alcohol Citric Acid Monohydrate Ethylhexylglycerin Polyhydroxystearic Acid (2300 Mw) Cladonia Rangiferina Whole Sunflower Oil Cocoa Butter Shea Butter Phenoxyethanol Levomenol Arachidyl Alcohol Arachidyl Glucoside Docosanol Butyloctyl Salicylate Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Water Cetyl Alcohol Coconut Oil Sclerocarya Birrea Seed Oil Tocopherol Microcrystalline Cellulose Hyaluronate Sodium Sodium Stearoyl Glutamate Coco Glucoside Diheptyl Succinate

Identifiers & Packaging

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

Zinc Oxide - 19.6%

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.

Dosage and Administration

Apply liberally 15 minutes before sun exposure.

Reapply:

-At least every two hours

-After 80 minutes of swimming or sweating.

-Immediately after towel drying.

Children under six 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.​

Description

Zinc Oxide - 19.6%

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

Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Capryloyl Glycerin/Sebacic Acid Copolymer, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Cladonia Stellaris Extract, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Seed Oil, Methyl Dihydroabietate, Microcrystalline Cellulose, Phenoxyethanol, Polyhydroxystearic Acid, Sclerocarya Birrea Seed Oil, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Water

Section 51945-4

Section 53413-1

Contact [email protected]

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide - 19.6%

Section 60561-8

Protect the product in this container from excessive heat and direct sun

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.

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure.

Reapply:

-At least every two hours

-After 80 minutes of swimming or sweating.

-Immediately after towel drying.

Children under six 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.​

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)

Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Capryloyl Glycerin/Sebacic Acid Copolymer, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Cladonia Stellaris Extract, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Seed Oil, Methyl Dihydroabietate, Microcrystalline Cellulose, Phenoxyethanol, Polyhydroxystearic Acid, Sclerocarya Birrea Seed Oil, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Contact [email protected]

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide - 19.6%

Section 60561-8 (60561-8)

Protect the product in this container from excessive heat and direct sun

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:00.104989 · Updated: 2026-03-14T23:06:15.168093