Protection 50 Body

Protection 50 Body
SPL v1
SPL
SPL Set ID 0b733772-8e37-4d0a-a824-defdab97ddc6
Route
TOPICAL
Published
Effective Date 2014-02-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octinoxate (75 mg)
Inactive Ingredients
Water Butylene Glycol Alkyl (c12-15) Benzoate Carthamus Tinctorius Seed Oleosomes Cyclomethicone 5 Aluminum Starch Octenylsuccinate Dimethyl Capramide Davana Oil Cananga Oil Orange Oil Grapefruit Oil Pelargonium Graveolens Flower Oil Tagetes Minuta Flower Oil Hyaluronate Sodium Glycyrrhizinate Dipotassium Arachidyl Alcohol Docosanol Arachidyl Glucoside Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Xanthan Gum Edetate Disodium Sodium Hydroxide Ethylhexylglycerin Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-08-08
Description

Drug Facts

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses
  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions), helps decrease the risk of skin cancer and early skin aging caused by the sun.
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Warnings

For external use only.

Directions
  • Apply liberally 30 minutes before sun exposure.
  • Reapply:
    • -
      At least every two hours.
    • -
      Use a water resistant sunscreen if swimming or sweating.
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To help 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: ask a doctor.
Other Information
  • Protect this product from excessive heat and direct sun.
Active Ingredients

Avobenzone 3.0%,

Octinoxate 7.5%

Inactive Ingredients

Water/Aqua/Eau, Butylene Glycol, C12-15 Alkyl Benzoate, Carthamus Tinctorius (Safflower) Oleosomes, Cyclopentasiloxane, Aluminum Starch Octenylsuccinate, Cetearyl Phosphate, Polyglyceryl-2 Stearate, Dimethyl Capramide, VP/Eicosene Copolymer, Artemisia Pallens Flower Oil, Cananga Odorata Flower Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Paradisi (Grapefruit) Peel Oil, Pelargonium Graveolens Flower Oil, Tagetes Minuta Flower Oil, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Caprylic/Capric Glycerides, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Disodium EDTA, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol.

Questions Or Comments

Call toll free 1-800-831-5150 in the US

Principal Display Panel 156 Ml Tube Carton

protection

50

sport

spf

50

broad

spectrum

UVA high protection

5.3 US FL OZ

156 mL e

dermalogica ®

Structured Label Content

Uses
  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions), helps decrease the risk of skin cancer and early skin aging caused by the sun.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Purpose

Sunscreen

Warnings

For external use only.

Directions
  • Apply liberally 30 minutes before sun exposure.
  • Reapply:
    • -
      At least every two hours.
    • -
      Use a water resistant sunscreen if swimming or sweating.
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To help 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: ask a doctor.
Other Information (Other information)
  • Protect this product from excessive heat and direct sun.
Active Ingredients

Avobenzone 3.0%,

Octinoxate 7.5%

Inactive Ingredients (Inactive ingredients)

Water/Aqua/Eau, Butylene Glycol, C12-15 Alkyl Benzoate, Carthamus Tinctorius (Safflower) Oleosomes, Cyclopentasiloxane, Aluminum Starch Octenylsuccinate, Cetearyl Phosphate, Polyglyceryl-2 Stearate, Dimethyl Capramide, VP/Eicosene Copolymer, Artemisia Pallens Flower Oil, Cananga Odorata Flower Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Paradisi (Grapefruit) Peel Oil, Pelargonium Graveolens Flower Oil, Tagetes Minuta Flower Oil, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Caprylic/Capric Glycerides, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Disodium EDTA, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol.

Questions Or Comments (Questions or comments)

Call toll free 1-800-831-5150 in the US

Principal Display Panel 156 Ml Tube Carton (PRINCIPAL DISPLAY PANEL - 156 mL Tube Carton)

protection

50

sport

spf

50

broad

spectrum

UVA high protection

5.3 US FL OZ

156 mL e

dermalogica ®

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:44.954091 · Updated: 2026-03-14T22:53:41.456865