Vacation - Spf 30 Mineral Lotion

Vacation - Spf 30 Mineral Lotion
SPL v2
SPL
SPL Set ID f69513ae-f210-075f-e053-2a95a90a9b2e
Route
TOPICAL
Published
Effective Date 2023-03-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (15.5 g)
Inactive Ingredients
Isododecane Magnesium Sulfate, Unspecified Methyl Dihydroabietate Polyglyceryl-4 Isostearate Propanediol Tocopherol Xanthan Gum Cucumber Allantoin Butyloctyl Salicylate Medium-chain Triglycerides Glycerin Caprylhydroxamic Acid Shea Butter Cetyl Alcohol Water Caprylyl Glycol Aloe Vera Leaf Alkyl (c12-15) Benzoate Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate Glyceryl Behenate/eicosadioate Isopropyl Myristate Niacinamide Polyhydroxystearic Acid (2300 Mw) Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate Polyglyceryl-3 Oleate Sodium Gluconate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-01

Description

Zinc Oxide 15.5%


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

Zinc Oxide 15.5%

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. In case of ingestion, get medical help or contact a Poison Control Center right away.

Section 51727-6

Allantoin, Aloe Barbadensis (Aloe Vera) Leaf Juice, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Alcohol , Cucumis Sativus (Cucumber) Fruit Extract, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Glycerin, Glyceryl Behenate/Eicosadioate, Isododecane, Isopropyl Myristate, Magnesium Sulfate, Methyl Dihydroabietate, Niacinamide (Vitamin B3), Polyglyceryl-3 Oleate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Propanediol, Sodium Gluconate, Tocopherol (Vitamin E), Water, Xanthan Gum

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide 15.5%

Directions

• Apply liberally 15 minutes before sun exposure.

• Reapply: after 80 minutes of swimming or sweating, immediately after towel 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 the 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

Other Information

• Protect this product 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

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. In case of ingestion, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Allantoin, Aloe Barbadensis (Aloe Vera) Leaf Juice, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Alcohol , Cucumis Sativus (Cucumber) Fruit Extract, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Glycerin, Glyceryl Behenate/Eicosadioate, Isododecane, Isopropyl Myristate, Magnesium Sulfate, Methyl Dihydroabietate, Niacinamide (Vitamin B3), Polyglyceryl-3 Oleate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Propanediol, Sodium Gluconate, Tocopherol (Vitamin E), Water, Xanthan Gum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide 15.5%

Directions

• Apply liberally 15 minutes before sun exposure.

• Reapply: after 80 minutes of swimming or sweating, immediately after towel 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 the 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

Other Information

• Protect this product from excessive heat and direct sun


Advanced Ingredient Data


Raw Label Data

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