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

Purpose

Sunscreen

Description

Octocrylene 4.0%, Zinc Oxide 5.0%


Medication Information

Warnings

For external use only

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

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

Other Information

protect this product from excessive heat and direct sun

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.

Description

Octocrylene 4.0%, Zinc Oxide 5.0%

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)

Do Not Use

on damaged or broken skin

Active Ingredients

Octocrylene 4.0%, Zinc Oxide 5.0%

Questions Or Comments?

Call 1-800-697-9868  Mon-Fri

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

Warnings

For external use only

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

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

Other Information (Other information)

protect this product from excessive heat and direct sun

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.

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)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients

Octocrylene 4.0%, Zinc Oxide 5.0%

Questions Or Comments? (Questions or comments?)

Call 1-800-697-9868  Mon-Fri

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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