Premium Moisturizing Sunscreen Spray Spf 30

Premium Moisturizing Sunscreen Spray Spf 30
SPL v2
SPL
SPL Set ID fb12e90f-9ac4-4267-81ee-1634c613a32c
Route
TOPICAL
Published
Effective Date 2021-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (50 mg) Octocrylene (37.5 mg)
Inactive Ingredients
Alcohol Alkyl (c12-15) Benzoate Dicaprylyl Carbonate Ppg-5-ceteth-20 Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-06-02

Description

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 3.75%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 3.75%

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

For external use only

Flammable: do not use near heat, flame, or while smoking

Directions

• hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • do not spray directly into face. Spray on hands then apply to face. • do not apply in windy conditions • use in well-ventilated area. • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months of age: 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

Do Not Use

on damaged or broken skin

Questions?

1-877-978-6286

Other Information

protect this product from excessive heat and direct sun

Package Labeling:

Active Ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 5%,

Octocrylene 3.75%

Inactive Ingredients

alcohol denat. (67%), acrylates/ octylacrylamide copolymer, C12-15 alkyl benzoate, dicaprylyl carbonate, PPG-5-ceteth-20, fragrance, tocopherol

When Using This Product

• keep out of eyes. Rinse with water to remove.

• use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

• do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

Stop Use and Ask A Doctor If

rash occurs

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center immediately.


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

Purpose

Sunscreen

Warnings

For external use only

Flammable: do not use near heat, flame, or while smoking

Directions

• hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • do not spray directly into face. Spray on hands then apply to face. • do not apply in windy conditions • use in well-ventilated area. • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months of age: 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

Do Not Use (Do not use)

on damaged or broken skin

Questions?

1-877-978-6286

Other Information (Other information)

protect this product from excessive heat and direct sun

Package Labeling:

Active Ingredients (Active ingredients)

Avobenzone 3%, Homosalate 10%, Octisalate 5%,

Octocrylene 3.75%

Inactive Ingredients (Inactive ingredients)

alcohol denat. (67%), acrylates/ octylacrylamide copolymer, C12-15 alkyl benzoate, dicaprylyl carbonate, PPG-5-ceteth-20, fragrance, tocopherol

When Using This Product (When using this product)

• keep out of eyes. Rinse with water to remove.

• use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

• do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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