Vacation - Spf 50 Super Spritz Face Mist

Vacation - Spf 50 Super Spritz Face Mist
SPL v3
SPL
SPL Set ID f67fbe98-93ce-2882-e053-2a95a90ab713
Route
TOPICAL
Published
Effective Date 2025-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (9.5 g) Octisalate (4.9 g) Avobenzone (2.9 g)
Inactive Ingredients
Succinic Acid Ethyl Ferulate Vinyl Acetate Water Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Sheanut Oil Caffeine Isobornyl Acrylate Green Tea Leaf Cucumber Seed Oil Coconut Tocopherol Dibutyl Maleate Levomenol Butyloctyl Salicylate Alcohol Aloe Vera Leaf Safflower Oil Chlorella Vulgaris Ethylhexyl Methoxycrylene Banana Passiflora Edulis Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-01

Description

Avobenzone (2.9%) Homosalate (4.9%) Octocrylene (9.5%)


Medication Information

Warnings and Precautions

For external use only

Do not use on damaged or broken skin

Flammable. Do not spray near heat, sparks, sources of ignition, or flames.

When using this product, keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Description

Avobenzone (2.9%) Homosalate (4.9%) Octocrylene (9.5%)

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

Alcohol, Aloe Barbadensis (Aloe Vera) Leaf Extract, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Oil, Caffeine, Camellia Sinensis (Green Tea) Leaf Extract, Carthamus Tinctorius (Safflower) Seed Oil, Chlorella Vulgaris Extract, Cocos Nucifera (Coconut) Extract, Cucumis Sativus (Cucumber) Seed Oil, Diisooctyl Succinate, Ethyl Ferulate, Ethylhexyl Methoxycrylene, Fragrance, Musa Sapientum (Banana) Fruit Extract, Passiflora Edulis Seed Oil, Polyester-8, Tocopherol (Vitamin E), VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Avobenzone (2.9%)

Homosalate (4.9%)

Octocrylene (9.5%)

Section 60561-8

Protect this product from excessive heat and direct sun.

Directions

• Hold spray 8-10 inches from face with eyes and mouth closed before using

• 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 sunglasses • Children under 6 months of age: ask a physician.


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

Flammable. Do not spray near heat, sparks, sources of ignition, or flames.

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)

Alcohol, Aloe Barbadensis (Aloe Vera) Leaf Extract, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Oil, Caffeine, Camellia Sinensis (Green Tea) Leaf Extract, Carthamus Tinctorius (Safflower) Seed Oil, Chlorella Vulgaris Extract, Cocos Nucifera (Coconut) Extract, Cucumis Sativus (Cucumber) Seed Oil, Diisooctyl Succinate, Ethyl Ferulate, Ethylhexyl Methoxycrylene, Fragrance, Musa Sapientum (Banana) Fruit Extract, Passiflora Edulis Seed Oil, Polyester-8, Tocopherol (Vitamin E), VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Avobenzone (2.9%)

Homosalate (4.9%)

Octocrylene (9.5%)

Section 60561-8 (60561-8)

Protect this product from excessive heat and direct sun.

Directions

• Hold spray 8-10 inches from face with eyes and mouth closed before using

• 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 sunglasses • Children under 6 months of age: ask a physician.


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Raw Label Data

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