Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 11f12fdb-4097-49e8-b467-165ca172be64
Route
TOPICAL
Published
Effective Date 2016-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octisalate (5 g) Octocrylene
Inactive Ingredients
Water Ethylhexyl Palmitate Propylene Glycol Benzyl Alcohol Glyceryl Monostearate Peg-100 Stearate Sodium Hydroxide Edetate Disodium Tocopherol Diethylhexyl Syringylidenemalonate Aloe Vera Leaf Sodium Ascorbyl Phosphate Medium-chain Triglycerides

Identifiers & Packaging

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

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%

Purpose

Sunscreen

Medication Information

Purpose


Sunscreen





Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%

Uses
  • helps prevent sunburn
  • is 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 15 or higher and other sun production measure 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

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%

Inactive Ingredients

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

Principle Display Label

NDC:  11822-1830-6

daylogic

SPORT

SUNSCREEN LOTION



BROAD SPECTRUM

SPF 30

UVA/UVB PROTECTION

WATER RESISTANT

(80 Minutes)

WON'T RUN INTO EYES

RECOMMENDED SKIN CARE FOUNDATION

ACTIVE

RECOMMENDED AS AN EFFECTIVE UVA/UVB SUNSCREEN

30

8 FL OZ (236 ml)



When Using This Product

keep out of eyes.  Rinse with water to remove.

Stop Use and Ask A Doctor

is 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
  • is 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 15 or higher and other sun production measure 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

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%

Inactive Ingredients

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

Principle Display Label

NDC:  11822-1830-6

daylogic

SPORT

SUNSCREEN LOTION



BROAD SPECTRUM

SPF 30

UVA/UVB PROTECTION

WATER RESISTANT

(80 Minutes)

WON'T RUN INTO EYES

RECOMMENDED SKIN CARE FOUNDATION

ACTIVE

RECOMMENDED AS AN EFFECTIVE UVA/UVB SUNSCREEN

30

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)

is 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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:05.580186 · Updated: 2026-03-14T22:54:18.927073