Silk Spf Facial Sunscreen Fluid Hybrid Broad Spectrum Spf 30 Uva/uvb

Silk Spf Facial Sunscreen Fluid Hybrid Broad Spectrum Spf 30 Uva/uvb
SPL v4
SPL
SPL Set ID d739bc43-d76e-9258-e053-2a95a90a3d2c
Route
TOPICAL
Published
Effective Date 2022-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (10.5 g) Homosalate (10 g)
Inactive Ingredients
Coco-caprylate/caprate Musa X Paradisiaca Flower Water Medium-chain Triglycerides Glyceryl Stearate Se Polyhydroxystearic Acid (2300 Mw) Sodium Phosphate, Dibasic, Anhydrous Sodium Phosphate Hydroxyethyl Cellulose, Unspecified Caprylyl Glycol Caprylhydroxamic Acid Coconut Alkanes Glycerin Decyl Glucoside Citric Acid Monohydrate Polyglyceryl-3 Pentaricinoleate Isostearic Acid Lecithin, Soybean Xanthan Gum Sodium Benzoate Starch, Rice

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-01 Until 2026-11-13

Description

Active Ingredients Zinc Oxide 10.5% Homosalate 10%


Medication Information

Warnings and Precautions



Warnings

For external use only.

Indications and Usage



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.

Dosage and Administration



Directions

Apply generously 15 minutes before sun

exposure. Reapply at least every 2 hours.

Use a water-resistant sunscreen if

swimming or sweating.

Description

Active Ingredients Zinc Oxide 10.5% Homosalate 10%

Section 50565-1



Keep out of reach of children. If

swallowed, get medical help or contact a

Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7



When using this product keep out of

eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6



Inactive Ingredients

water/aqua/eau, caprylic/capric

triglyceride, glyceryl stearate se, coconut

alkanes, glycerin, coco-caprylate/caprate,

decyl glucoside, oryza sativa (rice) starch,

musa sapientum (banana) flower extract,

polyhydroxystearic acid, polyglyceryl-3

polyricinoleate, isostearic acid, lecithin,

xanthan gum, hydroxyethylcellulose,

caprylyl glycol, caprylhydroxamic acid,

sodium benzoate, citric acid, disodium

phosphate, sodium phosphate.

Section 51945-4

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active Ingredients

Zinc Oxide 10.5%

Homosalate 10%

Section 60561-8



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. Children under 6

months of age: ask a doctor.


Structured Label Content

Indications and Usage (34067-9)



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.

Dosage and Administration (34068-7)



Directions

Apply generously 15 minutes before sun

exposure. Reapply at least every 2 hours.

Use a water-resistant sunscreen if

swimming or sweating.

Warnings and Precautions (34071-1)



Warnings

For external use only.

Section 50565-1 (50565-1)



Keep out of reach of children. If

swallowed, get medical help or contact a

Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)



When using this product keep out of

eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)



Inactive Ingredients

water/aqua/eau, caprylic/capric

triglyceride, glyceryl stearate se, coconut

alkanes, glycerin, coco-caprylate/caprate,

decyl glucoside, oryza sativa (rice) starch,

musa sapientum (banana) flower extract,

polyhydroxystearic acid, polyglyceryl-3

polyricinoleate, isostearic acid, lecithin,

xanthan gum, hydroxyethylcellulose,

caprylyl glycol, caprylhydroxamic acid,

sodium benzoate, citric acid, disodium

phosphate, sodium phosphate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active Ingredients

Zinc Oxide 10.5%

Homosalate 10%

Section 60561-8 (60561-8)



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. Children under 6

months of age: ask a doctor.


Advanced Ingredient Data


Raw Label Data

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