fc42ff16-0bd3-43d1-a2b7-02e2814a1d9c

SPL v1
SPL
SPL Set ID fc42ff16-0bd3-43d1-a2b7-02e2814a1d9c
Route
topical
Published
Effective Date 2018-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 g) homosalate (12 g) octisalate (5 g) octocrylene
Inactive Ingredients
butylated hydroxytoluene levomenol butylene glycol alkyl (c12-15) benzoate capryloyl glycine caprylyl glycol cedrus atlantica bark cinnamon bark oil cyclomethicone 5 edetate disodium ethylhexyl stearate ethylhexylglycerin yeast mannan neopentyl glycol diheptanoate phenoxyethanol polyester-7 propylene glycol purslane sarcosine steareth-2 steareth-100 trideceth-6 phosphate water xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2013-04-10

Purpose

Avobenzone 3%, Homosalate 12%, Octisalate 5%, Octocrylene 3%.........................................................Sunscreen

Description

Avobenzone 3%, Homosalate 12%, Octisalate 5%, Octocrylene 3%.........................................................Sunscreen


Medication Information

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

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

Uses • helps prevent sunburn

Purpose

Avobenzone 3%, Homosalate 12%, Octisalate 5%, Octocrylene 3%.........................................................Sunscreen

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 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

Other Information

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



Questions or comments?

1-800-Wegmans(934-6267) Ext 5920

9am - 4pm EST weekdays.

Inactive Ingredients

 Acrylates/Dimethicone Copolymer

BHT

Bisabolol

Butylene Glycol

C12-15 Alkyl Benzoate

Capryloyl Glycine

Caprylyl Glycol

Cedrus Atlantica Bark Extract

Cetyl Dimethicone

Chlorphenesin

Cinnamomum Zeylanicum Bark Extract

Cyclopentasiloxane

Disodium EDTA

Ethylhexyl Stearate

Ethylhexylglycerin

Mannan

Neopentyl Glycol Diheptanoate

Phenoxyethanol

Polyester-7

Polyester-8

Portulaca Oleracea Extract

Propylene Glycol

Sarcosine

Silica

Sodium Polyacrylate

Steareth-2

Steareth-100

Styrene/Acrylates Copolymer

Trideceth-6

Water

Xanthan Gum

Description

Avobenzone 3%, Homosalate 12%, Octisalate 5%, Octocrylene 3%.........................................................Sunscreen

Section 51945-4

Active Ingredients                         Purpose

Avobenzone 3%, Homosalate 12%,

Octisalate 5%, Octocrylene 3%.........................................................Sunscreen


Structured Label Content

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

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage (34067-9)

Uses • helps prevent sunburn

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 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

Other Information (Other information)

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



Questions or comments?

1-800-Wegmans(934-6267) Ext 5920

9am - 4pm EST weekdays.

Inactive Ingredients (Inactive ingredients)

 Acrylates/Dimethicone Copolymer

BHT

Bisabolol

Butylene Glycol

C12-15 Alkyl Benzoate

Capryloyl Glycine

Caprylyl Glycol

Cedrus Atlantica Bark Extract

Cetyl Dimethicone

Chlorphenesin

Cinnamomum Zeylanicum Bark Extract

Cyclopentasiloxane

Disodium EDTA

Ethylhexyl Stearate

Ethylhexylglycerin

Mannan

Neopentyl Glycol Diheptanoate

Phenoxyethanol

Polyester-7

Polyester-8

Portulaca Oleracea Extract

Propylene Glycol

Sarcosine

Silica

Sodium Polyacrylate

Steareth-2

Steareth-100

Styrene/Acrylates Copolymer

Trideceth-6

Water

Xanthan Gum

Section 51945-4 (51945-4)

Active Ingredients                         Purpose (Active ingredients                         Purpose)

Avobenzone 3%, Homosalate 12%,

Octisalate 5%, Octocrylene 3%.........................................................Sunscreen


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)