drug facts

drug facts
SPL v3
SPL
SPL Set ID 2ea84d12-a5da-41a3-986b-8897f287f00f
Route
topical
Published
Effective Date 2016-03-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (2.0 g) homosalate (5.5 g) octocrylene (4.0 g) octisalate (4.5 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 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 2015-07-14

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 sun protection measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.

  • wear long-sleeve 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 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 59779-911-16

CVS pharmacy

30

SHEER SUN LOTION

BROAD SPECTRUM SPF 30

UVA/UVB protection

sunscreen

Moisturizing formula with shea butter

Oil free, lightweight sheer protection

Water resistant (80 minutes)

Dermatologist tested

COMPARE TO HAWAIIN TROPIC

SHEER TOUCH LOTION

8.0 FL OZ (237 mL)

Do Not Use

on damaged or broken skin

Active Ingredients

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



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. - 2 p.m.

  • wear long-sleeve 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 (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 (principal Display panel)

NDC 59779-911-16

CVS pharmacy

30

SHEER SUN LOTION

BROAD SPECTRUM SPF 30

UVA/UVB protection

sunscreen

Moisturizing formula with shea butter

Oil free, lightweight sheer protection

Water resistant (80 minutes)

Dermatologist tested

COMPARE TO HAWAIIN TROPIC

SHEER TOUCH LOTION

8.0 FL OZ (237 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%



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

All Sections (JSON)