Vacation - Spf 30 Chardonnay Oil

Vacation - Spf 30 Chardonnay Oil
SPL v2
SPL
SPL Set ID f694752d-4839-3768-e053-2995a90a5d3e
Route
TOPICAL
Published
Effective Date 2023-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (9.8 g) Octisalate (4.9 g) Avobenzone (2.9 g) Octocrylene (9.5 g)
Inactive Ingredients
Levomenol Butyloctyl Salicylate Alkyl (c12-15) Benzoate Trimethylpentanediol/adipic Acid/glycerin Crosspolymer (25000 Mpa.s) Medium-chain Triglycerides Methyl Dihydroabietate Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Jojoba Oil Tocopherol Isopropyl Myristate Sheanut Oil Passiflora Edulis Seed Oil Grape Seed Oil Sclerocarya Birrea Seed Oil

Identifiers & Packaging

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

Description

Avobenzone (2.9%) Homosalate (9.8%) Octisalate (4.9%) Octocrylene (9.5%)


Medication Information

Description

Avobenzone (2.9%) Homosalate (9.8%) Octisalate (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

Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Oil, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Fragrance, Isopropyl Myristrate, Methyl Dihydroabietate, Passiflora Edulis (Passionfruit) Seed Oil, Polyester-8, Sclerocarya Birrea (Marula) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E),Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Vitis Vinifera (Chardonnay Grape) Seed Oil

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Avobenzone (2.9%)

Homosalate (9.8%)

Octisalate (4.9%)

Octocrylene (9.5%)

Warnings

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

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

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.

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)

Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Oil, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Fragrance, Isopropyl Myristrate, Methyl Dihydroabietate, Passiflora Edulis (Passionfruit) Seed Oil, Polyester-8, Sclerocarya Birrea (Marula) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E),Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Vitis Vinifera (Chardonnay Grape) Seed Oil

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Avobenzone (2.9%)

Homosalate (9.8%)

Octisalate (4.9%)

Octocrylene (9.5%)

Warnings

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

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

Other Information

• Protect this product from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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