drub facts

drub facts
SPL v1
SPL
SPL Set ID f8f721a6-d2a8-48ba-a9c0-98b2a29ecafe
Route
topical
Published
Effective Date 2016-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (2 g) homosalate (5.5 g) octisalate (4.5 g) octocrylene (4 g)
Inactive Ingredients
water 2-ethylhexyl benzoate cetostearyl alcohol diisopropyl adipate neopentyl glycol diheptanoate mica dimethicone glycerin coco glucoside propylene glycol dibenzoate ceteth-10 phosphate dihexadecyl phosphate edetate disodium paraffin xanthan gum shea butter jojoba butter mangifera indica seed butter propanediol .alpha.-tocopherol acetate papaya colocasia esculenta root mango passiflora incarnata fruit plumeria rubra flower guava panthenol aloe vera leaf sodium ascorbyl phosphate phenoxyethanol methylparaben propylparaben titanium dioxide

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2016-03-10

Purpose

Sunscreen

Description

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0%


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 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: Ask a doctor

Other Information

protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Ethylhexyl Benzoate, Cetearyl Alcohol, VP/Eicosene Copolymer, Diisopropyl Adipate, Neopentyl Glycol Diheptanoate, Mica, Dimethicone, Glycerin, Polymethylsilsesquioxane, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Coco-Glucoside, Propylene Glycol Dibenzoate, Ceteth-10 Phosphate, Dicetyl Phosphate, Disodium EDTA, Paraffin, Xanthan Gum,  Butyrospermum Parkii (Shea) Butter, Jojoba Alcohol, Potassium Jojobate, Simmondsia Chinensis (Jojoba) Butter, Mangifera Indica (Mango) Seed Butter, Propanediol, Tocopheryl Acetate, Carica Papaya (Papaya) Fruit Extract, Colocasia Antiquorum Root Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Panthenol, Aloe Barbadensis Leaf Juice, Sodium Ascorbyl Phosphate, Phenoxyethanol, Methylparaben, Propylparaben, Fragrance, Titanium Dioxide.

Description

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0%

Principal Display Panel


NDC 41250-103-56

meijer

Sheer Sunscreen Lotion

moisturizing

UVA/UVB protection

30

Broad Spectrum SPF 30

Water Resistant

(80 Minutes)

Contains Shea Butter and

Mango Fruit Extract

8 FL OZ (236 mL)











Do Not Use

on damaged or broken skin

Active Ingredients

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0%

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 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: Ask a doctor

Other Information (Other information)

protect this product from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

Water, Ethylhexyl Benzoate, Cetearyl Alcohol, VP/Eicosene Copolymer, Diisopropyl Adipate, Neopentyl Glycol Diheptanoate, Mica, Dimethicone, Glycerin, Polymethylsilsesquioxane, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Coco-Glucoside, Propylene Glycol Dibenzoate, Ceteth-10 Phosphate, Dicetyl Phosphate, Disodium EDTA, Paraffin, Xanthan Gum,  Butyrospermum Parkii (Shea) Butter, Jojoba Alcohol, Potassium Jojobate, Simmondsia Chinensis (Jojoba) Butter, Mangifera Indica (Mango) Seed Butter, Propanediol, Tocopheryl Acetate, Carica Papaya (Papaya) Fruit Extract, Colocasia Antiquorum Root Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Panthenol, Aloe Barbadensis Leaf Juice, Sodium Ascorbyl Phosphate, Phenoxyethanol, Methylparaben, Propylparaben, Fragrance, Titanium Dioxide.

Principal Display Panel


NDC 41250-103-56

meijer

Sheer Sunscreen Lotion

moisturizing

UVA/UVB protection

30

Broad Spectrum SPF 30

Water Resistant

(80 Minutes)

Contains Shea Butter and

Mango Fruit Extract

8 FL OZ (236 mL)











Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0%

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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