Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 7503de5b-53c9-416d-b5de-e0526752098d
Route
TOPICAL
Published
Effective Date 2016-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (11.7 g) Octisalate (4.5 g) Octocrylene (5.4 g) Oxybenzone
Inactive Ingredients
Water Neopentyl Glycol Diheptanoate Propylene Glycol Chlorphenesin Glyceryl Monostearate Peg-100 Stearate Edetate Disodium Sodium Hydroxide Tocopherol Aloe Vera Leaf Sodium Ascorbyl Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-03-04

Description

Avobenzone 3.0%, Homosalate 11.7%, Octisalate 4.5%, Octocrylene 4.5%, Oxybenzone 5.4%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 11.7%, Octisalate 4.5%, Octocrylene 4.5%, Oxybenzone 5.4%

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases 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. - 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

Avobenzone 3.0%, Homosalate 11.7%, Octisalate 4.5%, Octocrylene 4.5%, Oxybenzone 5.4%

Inactive Ingredients

Water, Neopentyl Glycol Diheptanoate, Propylene Glycol, Polyglyceryl-3 Methylglucose Distearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Styrene/Acrylates Copolymer, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glyceryl Stearate, PEG-100 Stearate, Fragrance, Disodium EDTA, Sodium Hydroxide, Tocopherol, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate.

Principle Display Label

NDC: 11822-1840-6

daylogic

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM

SPF 50

UVA/UVB PROTECTION

WATER RESISTANT

(80 minutes)

WON'T RUN INTO EYES

RECOMMENDED SKIN CARE FOUNDATION ACTIVE

RECOMMENDED AS AN EFFECTIVE UVA/UVB SUNSCREEN

50

8 FL OZ (236 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 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. - 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

protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 3.0%, Homosalate 11.7%, Octisalate 4.5%, Octocrylene 4.5%, Oxybenzone 5.4%

Inactive Ingredients

Water, Neopentyl Glycol Diheptanoate, Propylene Glycol, Polyglyceryl-3 Methylglucose Distearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Styrene/Acrylates Copolymer, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glyceryl Stearate, PEG-100 Stearate, Fragrance, Disodium EDTA, Sodium Hydroxide, Tocopherol, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate.

Principle Display Label

NDC: 11822-1840-6

daylogic

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM

SPF 50

UVA/UVB PROTECTION

WATER RESISTANT

(80 minutes)

WON'T RUN INTO EYES

RECOMMENDED SKIN CARE FOUNDATION ACTIVE

RECOMMENDED AS AN EFFECTIVE UVA/UVB SUNSCREEN

50

8 FL OZ (236 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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