Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 5a9c2f6d-1be4-47a8-9825-58f8a6b1ec0b
Route
TOPICAL
Published
Effective Date 2018-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (15 g) Octisalate (5 g) Octocrylene (2.75 g) Oxybenzone (6 g)
Inactive Ingredients
Alcohol Ascorbyl Palmitate Cyclomethicone 5 Dimethicone Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Ppg-5-ceteth-20 Vitamin A Palmitate .alpha.-tocopherol Acetate Trisiloxane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-12-13

Description

Active ingredients Purpose Avobenzone 3.00%, Homosalate 15.00%, Octisalate 5.00%, Octocrylene 2.75%, Oxybenzone 6.00%.


Medication Information

Warnings and Precautions

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 eyes with water

to remove. • Keep away from face to avoid breathing it • Do not

puncture or incinerate. Contents under pressure. Do not store at

temperatures above 120ºF.

Stop use and ask a doctor if rash occurs

Indications and Usage

Uses • helps prevent sunburn

Description

Active ingredients Purpose Avobenzone 3.00%, Homosalate 15.00%, Octisalate 5.00%, Octocrylene 2.75%, Oxybenzone 6.00%.

Section 51727-6

Inactive ingredients

Acrylates Dimethicone Copolymer,

Acrylates/Octylacrylamide Copolymer, Alcohol Denat., Ascorbyl Palmitate,

Cyclopentasiloxane, Dimethicone, Fragrance,

Polyester-8, PPG-5-Ceteth-20, Retinyl Palmitate,

Tocopheryl Acetate, Trisiloxane.

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Active ingredients Purpose

Avobenzone 3.00%, Homosalate 15.00%,

Octisalate 5.00%, Octocrylene 2.75%,

Oxybenzone 6.00%.

Section 60561-8

Other information • protect this product from excessive heat and direct sun • may stain fabrics

Directions



• spray liberally and spread evenly by hand 15 minutes before sun exposure

• reapply: • after 80 minutes of swimming or sweating

• immediately after towel drying • at least every 2 hours

• hold container 4 to 6 inches from the skin to apply • do not spray directly

into face. Spray on hands then apply to face. • do not apply in windy

conditions • use in a well-ventilated area

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 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: Ask a doctor

Keep Out of Reach of Children.

If product is swallowed, get medical

help or contact a Poison Control Center right away.


Structured Label Content

Indications and Usage (34067-9)

Uses • helps prevent sunburn

Warnings and Precautions (34071-1)

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 eyes with water

to remove. • Keep away from face to avoid breathing it • Do not

puncture or incinerate. Contents under pressure. Do not store at

temperatures above 120ºF.

Stop use and ask a doctor if rash occurs

Section 51727-6 (51727-6)

Inactive ingredients

Acrylates Dimethicone Copolymer,

Acrylates/Octylacrylamide Copolymer, Alcohol Denat., Ascorbyl Palmitate,

Cyclopentasiloxane, Dimethicone, Fragrance,

Polyester-8, PPG-5-Ceteth-20, Retinyl Palmitate,

Tocopheryl Acetate, Trisiloxane.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Active ingredients Purpose

Avobenzone 3.00%, Homosalate 15.00%,

Octisalate 5.00%, Octocrylene 2.75%,

Oxybenzone 6.00%.

Section 60561-8 (60561-8)

Other information • protect this product from excessive heat and direct sun • may stain fabrics

Directions



• spray liberally and spread evenly by hand 15 minutes before sun exposure

• reapply: • after 80 minutes of swimming or sweating

• immediately after towel drying • at least every 2 hours

• hold container 4 to 6 inches from the skin to apply • do not spray directly

into face. Spray on hands then apply to face. • do not apply in windy

conditions • use in a well-ventilated area

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 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: Ask a doctor

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

If product is swallowed, get medical

help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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