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
Purpose

Sunscreen

Description

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

Medication Information

Warnings

For external use only

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





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

Other Information

protect this product from excessive heat and direct sun

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.

Description

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

Do Not Use

on damaged or broken skin

Active Ingredients

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

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

Warnings

For external use only

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





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

Other Information (Other information)

protect this product from excessive heat and direct sun

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.

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients

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

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