Indications and 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.
Protection 50 Body
- Manufacturer
- Dermalogica, Inc. | Cosway | Diamond Wipes
- Effective date
- 2014-02-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:38:23
Label at a glance#
ProductProtection 50 Body
Active ingredientAvobenzone, Octinoxate
Label structure10 sections
Dosage and administration
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, ...
Storage and handling
Protect this product from excessive heat and direct sun.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredients
Avobenzone 3.0%,
Octinoxate 7.5%
Purpose
Sunscreen
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.
Warnings
For external use only.
OTC - DO NOT USE SECTION
Do not use on damaged or broken skin.
OTC - WHEN USING SECTION
When using this product keep out of eyes. Rinse with water to remove.
OTC - STOP USE SECTION
Stop use and ask a doctor if rash occurs.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
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.
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®
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68479-230-00 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1e85-f424-e053-dadaa90a57ce | Protection 50 Body |
| 68479-230-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1e85-f424-e053-dadaa90a57ce | Protection 50 Body |
| 68479-230-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1e85-f424-e053-dadaa90a57ce | Protection 50 Body |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68479-230-00 | Protection 50 Body | 2 mL in 1 POUCH | LOTION | 2 | 1 | |
| 68479-230-01 | Protection 50 Body | 22 mL in 1 TUBE | LOTION | 22 | 1 | |
| 68479-230-02 | Protection 50 Body | 156 mL in 1 TUBE | LOTION | 156 | 1 | |
| 68479-230-02 | Protection 50 Body | 1 in 1 CARTON | LOTION | 1 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Avobenzone | ACTIVE INGREDIENT | G63QQF2NOX | 1 | |
| Octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| Avobenzone | ACTIVE MOIETY | G63QQF2NOX | 1 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| Alkyl (C12-15) Benzoate | INACTIVE INGREDIENT | A9EJ3J61HQ | 1 | |
| Aluminum Starch Octenylsuccinate | INACTIVE INGREDIENT | I9PJ0O6294 | 1 | |
| Arachidyl Alcohol | INACTIVE INGREDIENT | 1QR1QRA9BU | 1 | |
| Arachidyl Glucoside | INACTIVE INGREDIENT | 6JVW35JOOJ | 1 | |
| Butylene Glycol | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| Cananga Oil | INACTIVE INGREDIENT | 8YOY78GNNX | 1 | |
| Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) | INACTIVE INGREDIENT | 59TL3WG5CO | 1 | |
| Carthamus Tinctorius Seed Oleosomes | INACTIVE INGREDIENT | 9S60Q72309 | 1 | |
| Cyclomethicone 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| Davana Oil | INACTIVE INGREDIENT | CL439Y041G | 1 | |
| Dimethyl Capramide | INACTIVE INGREDIENT | O29Y6X2JEZ | 1 | |
| Docosanol | INACTIVE INGREDIENT | 9G1OE216XY | 1 | |
| Edetate Disodium | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| Ethylhexylglycerin | INACTIVE INGREDIENT | 147D247K3P | 1 | |
| Glycyrrhizinate Dipotassium | INACTIVE INGREDIENT | CA2Y0FE3FX | 1 | |
| Grapefruit Oil | INACTIVE INGREDIENT | YR377U58W9 | 1 | |
| Hyaluronate Sodium | INACTIVE INGREDIENT | YSE9PPT4TH | 1 | |
| Orange Oil | INACTIVE INGREDIENT | AKN3KSD11B | 1 | |
| Pelargonium Graveolens Flower Oil | INACTIVE INGREDIENT | 3K0J1S7QGC | 1 | |
| Phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| Tagetes Minuta Flower Oil | INACTIVE INGREDIENT | 1T0ZMU8M8B | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| Xanthan Gum | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- Protection 50 Body
- Avobenzone and Octinoxate
- Avobenzone
- Octinoxate
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68479-230 | 68479-230-02, 68479-230-01, 68479-230-00 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRALESIONAL | ADJ PH | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, DELAYED RELEASE / ORAL | 100 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CONCENTRATE / ORAL | 10 mg/5ml | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CREAM / VAGINAL | 0.19 %w/w | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / EXTRACORPOREAL | ADJ PH | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / ORAL | 4 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRASYNOVIAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / AURICULAR (OTIC) | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / PERIDURAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRATHECAL | 176 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE, DELAYED RELEASE / ORAL | 0.25 mg | ||
| Orange Oil | ORANGE OIL, COLD PRESSED | AKN3KSD11B | SUSPENSION / ORAL | 1 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | JELLY / TOPICAL | ADJ PH | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL, FOAM / TOPICAL | 72 mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET / ORAL | 100 mg | ||
| Orange Oil | ORANGE OIL, COLD PRESSED | AKN3KSD11B | TABLET / SUBLINGUAL | NA | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | DROPS / OPHTHALMIC | NA | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | ELIXIR / ORAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GEL / TOPICAL | 70 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SPONGE / TOPICAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | CREAM, AUGMENTED / TOPICAL | 10 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / TOPICAL | 1 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SOLUTION / OPHTHALMIC | 0.6 %w/v | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | GEL / TOPICAL | 24 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | GEL / OPHTHALMIC | 396 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / DENTAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRACAVITARY | ADJ PH | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET / ORAL | 56 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRALESIONAL | 0.05 %w/v | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | PASTE / ORAL | 1050 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRADISCAL | ADJ PH | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION/ DROPS / ORAL | 22 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE / ORAL | 60 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAMUSCULAR | 176 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | LOTION / TOPICAL | 22 mg | ||
| Hyaluronate Sodium | HYALURONATE SODIUM | YSE9PPT4TH | INJECTION, SUSPENSION / INTRA-ARTICULAR | 23 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | ADJ PH | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | AEROSOL, FOAM / TOPICAL | 0.27 %w/w | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | GEL / TRANSDERMAL | 1 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / OPHTHALMIC | 1 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | FILM, SOLUBLE / ORAL | 11 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CREAM, AUGMENTED / TOPICAL | 6 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | DISC / TOPICAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / SUBCUTANEOUS | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | AEROSOL, FOAM / TOPICAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRALESIONAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CREAM / TOPICAL | 69 mg | ||
| Hyaluronate Sodium | HYALURONATE SODIUM | YSE9PPT4TH | LOTION / TOPICAL | 0.01 %w/w | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SUSPENSION / ORAL | 600 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | DROPS / NASAL | 0.1 mg/1ml | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SOLUTION / ORAL | 10 mg/5ml | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAVITREAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAPLEURAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRACARDIAC | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 136.55 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING / ORAL | 0.15 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f245ca49-37d6-4fee-9d1a-bbf838030c47 | 0b733772-8e37-4d0a-a824-defdab97ddc6 | 2014-02-04 | Warnings | f245ca49-37d6-4fee-9d1a-bbf838030c47 0b733772-8e37-4d0a-a824-defdab97ddc6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.