SPL v4
SPL
SPL Set ID ab1609b7-a10b-44f3-ab86-a615967b2a57
Route
TOPICAL
Published
Effective Date 2021-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g) Titanium Dioxide (3.3 g) Zinc Oxide (13.8 g)
Inactive Ingredients
Water Alcohol Mandelic Acid Glycerin Purslane Butylene Glycol Phenoxyethanol Ethylhexylglycerin Cyclomethicone 5 Peg-10 Dimethicone (600 Cst) Hydrogenated Polydecene Type I Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer Hydrogen Dimethicone (13 Cst) Acrylic Acid/ethylene Copolymer (600 Mpa.s) Silicon Dioxide Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Disteardimonium Hectorite Olea Europaea Leaf Sodium Chloride Aluminum Hydroxide Allantoin Sodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-01

Description

Salicylic Acid 2%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic Acid 2%

Uses

• For the treatment of acne

• Helps prevent development of new acne blemishes

Warnings

For External Use Only

Do not use if

• are pregnant

• are a child under 3 years of age

• are allergic to salicylates

When using this product

• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

• Avoid unnecessary sun exposure and use a sunscreen.

• Avoid contact with the eyes, lips and mouth.

• First time users may experience tingling sensation and visible peeling. After frequent usage, tingling and peeling will likely reduce.

Stop use and ask a doctor if

• Irritation becomes severe

Direction

• Cleanse the skin thoroughly before applying this product

• For treatment of acne, wet cotton bud or pad with solution and cover the entire affected area with a thin layer one to three times daily. Suitable for both facial and body acne.

• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.

• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

• Complement this with other Skinlycious products to reduce the likelihood of skin dryness.

• For full face exfoliant, wet cotton pad with a solution and apply a thin layer in the evening only over the entire face. No need to rinse off. Once skin condition improves, reduce frequency to no more than 3-5 times a week in the evening only.

Directions

• Apply liberally 15 minutes before sun exposure.

• Apply to all skin exposed to the sun.

• Reapply at least every 2 hours.

• Use a water resistant sunscreen if swimming or sweating.

• Children under 6 months: 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 10a.m.-2p.m.

- wear long-sleeved shirts, pants, hats and sunglasses.

Product Label

Active Ingredient

Salicylic Acid 2%

Other Information

• Store in a cool dry place away from direct sun.

Active Ingredients

Titanium Dioxide 3.3%

Zinc Oxide 13.8%

Inactive Ingredients

Water, Alcohol Denat. Mandelic Acid, Glycerin, Purslane, Butylene Glycol, Phenoxyethanol, Ethylhexylglycerin.

Questions Or Comments

(302) 291-7376

Keep Out of Reach of Children

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

Drug Facts For skinlycious Glow Exfoliant

Drug Facts For skinlycious Multi Protection Mineral Sunscreen Broad Spectrum Spf 30


Structured Label Content

Uses

• For the treatment of acne

• Helps prevent development of new acne blemishes

Purpose

Acne treatment

Warnings

For External Use Only

Do not use if

• are pregnant

• are a child under 3 years of age

• are allergic to salicylates

When using this product

• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

• Avoid unnecessary sun exposure and use a sunscreen.

• Avoid contact with the eyes, lips and mouth.

• First time users may experience tingling sensation and visible peeling. After frequent usage, tingling and peeling will likely reduce.

Stop use and ask a doctor if

• Irritation becomes severe

Direction

• Cleanse the skin thoroughly before applying this product

• For treatment of acne, wet cotton bud or pad with solution and cover the entire affected area with a thin layer one to three times daily. Suitable for both facial and body acne.

• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.

• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

• Complement this with other Skinlycious products to reduce the likelihood of skin dryness.

• For full face exfoliant, wet cotton pad with a solution and apply a thin layer in the evening only over the entire face. No need to rinse off. Once skin condition improves, reduce frequency to no more than 3-5 times a week in the evening only.

Directions

• Apply liberally 15 minutes before sun exposure.

• Apply to all skin exposed to the sun.

• Reapply at least every 2 hours.

• Use a water resistant sunscreen if swimming or sweating.

• Children under 6 months: 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 10a.m.-2p.m.

- wear long-sleeved shirts, pants, hats and sunglasses.

Product Label (Product label)

Active Ingredient (Active ingredient)

Salicylic Acid 2%

Other Information (Other information)

• Store in a cool dry place away from direct sun.

Active Ingredients (Active ingredients)

Titanium Dioxide 3.3%

Zinc Oxide 13.8%

Inactive Ingredients

Water, Alcohol Denat. Mandelic Acid, Glycerin, Purslane, Butylene Glycol, Phenoxyethanol, Ethylhexylglycerin.

Questions Or Comments (Questions or Comments)

(302) 291-7376

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

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

Drug Facts For skinlycious Glow Exfoliant (Drug Facts for Skinlycious Glow Exfoliant)

Drug Facts For skinlycious Multi Protection Mineral Sunscreen Broad Spectrum Spf 30 (Drug Facts for Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30)


Advanced Ingredient Data


Raw Label Data

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