Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 9983f672-da35-4b1b-802c-aa4c1490d720
Route
TOPICAL
Published
Effective Date 2016-04-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (4 g) Zinc Oxide (5 g)
Inactive Ingredients
Water Ethylhexyl Stearate Diisopropyl Adipate Polyglyceryl-4 Isostearate Hexyl Laurate Yellow Wax Isohexadecane Sodium Chloride Hydrogenated Castor Oil Silicon Dioxide Triethoxycaprylylsilane Dimethicone Tocopherol Edetate Disodium Aloe Vera Leaf Sodium Ascorbyl Phosphate Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-03-10

Description

Octocrylene 4.0%, Zinc Oxide 5.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octocrylene 4.0%, Zinc Oxide 5.0%

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

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. to 2 p.m.

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

•    children under 6 months of age: Ask a doctor

Do Not Use

on damaged or broken skin

Other Information

protect this product from excessive heat and direct sun

Active Ingredients

Octocrylene 4.0%, Zinc Oxide 5.0%

Inactive Ingredients

Water, Ethylhexyl Stearate, Diisopropyl Adipate, Cetyl Dimethicone, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Beeswax, Isohexadecane, Sodium Chloride, Hydrogenated Castor Oil, Silica, Triethoxycaprylylsilane, Dimethicone, Tocopherol, Disodium EDTA, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate,  henoxyethanol, Methylparaben, Propylparaben.

Questions Or Comments?

Call 1-800-697-9868  Mon-Fri

Principal Display Panel

NDC:  41250-796-83

meijer

Vanishing Zinc

Sunscreen

Lotion

Dermatologist tested

UVA/UVB protection

50

Broad Spectrum

SPF 50

Water Resistant

(80 minutes)

Non-greasy

Goes on clear

4 FL. OZ.  (118 mL)

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.

•    May stain some fabrics


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

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. to 2 p.m.

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

•    children under 6 months of age: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)

protect this product from excessive heat and direct sun

Active Ingredients

Octocrylene 4.0%, Zinc Oxide 5.0%

Inactive Ingredients (Inactive ingredients)

Water, Ethylhexyl Stearate, Diisopropyl Adipate, Cetyl Dimethicone, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Beeswax, Isohexadecane, Sodium Chloride, Hydrogenated Castor Oil, Silica, Triethoxycaprylylsilane, Dimethicone, Tocopherol, Disodium EDTA, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate,  henoxyethanol, Methylparaben, Propylparaben.

Questions Or Comments? (Questions or comments?)

Call 1-800-697-9868  Mon-Fri

Principal Display Panel

NDC:  41250-796-83

meijer

Vanishing Zinc

Sunscreen

Lotion

Dermatologist tested

UVA/UVB protection

50

Broad Spectrum

SPF 50

Water Resistant

(80 minutes)

Non-greasy

Goes on clear

4 FL. OZ.  (118 mL)

When Using This Product (When using this product)

keep out of eyes.  Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

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.

•    May stain some fabrics


Advanced Ingredient Data


Raw Label Data

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