Premium Moisturizing Sunscreen Broad Spectrum Spf 70

Premium Moisturizing Sunscreen Broad Spectrum Spf 70
SPL v3
SPL
SPL Set ID 36da7117-1c8e-7fcf-e063-6294a90aed00
Route
TOPICAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octocrylene (100 mg) Homosalate (50 mg) Octisalate
Inactive Ingredients
.alpha.-tocopherol Acetate Trisiloxane Caprylic/capric Triglyceride Ascorbyl Palmitate Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Dimethicone Ppg-5-ceteth-20 Alcohol Acrylates/octylacrylamide Copolymer (40000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

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

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

Do not use on damaged or broken skin

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.

Directions

• shake well before use

• 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 onto face. Spray on hands then apply to face.

• do not apply in windy conditions

• use in a well-ventilated area

•Avoid inhaling or exposing others to spray

• 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

Questions?

1-877-978-6286

Other Information

protect this product from excessive heat and direct sun

Primary Packaging

Active Ingredients

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

Inactive Ingredients

alcohol denat. (65%), polyester-8, acrylates/octylacrylamide copolymer, ascorbyl palmitate, caprylic/capric triglyceride, dimethicone, fragrance, PPG-5-ceteth-20, tocopheryl acetate, trisiloxane


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

Do not use on damaged or broken skin

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.

Directions

• shake well before use

• 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 onto face. Spray on hands then apply to face.

• do not apply in windy conditions

• use in a well-ventilated area

•Avoid inhaling or exposing others to spray

• 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

Questions?

1-877-978-6286

Other Information

protect this product from excessive heat and direct sun

Primary Packaging

Active Ingredients

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

Inactive Ingredients

alcohol denat. (65%), polyester-8, acrylates/octylacrylamide copolymer, ascorbyl palmitate, caprylic/capric triglyceride, dimethicone, fragrance, PPG-5-ceteth-20, tocopheryl acetate, trisiloxane


Advanced Ingredient Data


Raw Label Data

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