Indications and uses
•helps prevent sunburn. •if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Pro-Tect Sports Sunscreen SPF 20
- Manufacturer
- A-Cute Derm, Incorporated | Bio-Medical & Pharmaceutical Manufacturing Corporation
- Effective date
- 2021-12-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-05-31 23:45:50
Label at a glance#
ProductPro-Tect Sports Sunscreen SPF 20
Active ingredientOCTINOXATE, MERADIMATE, OXYBENZONE, OCTISALATE
Label structure10 sections
Dosage and administration
•apply liberally 15 minutes before sun exposure •reapply: •after 80 minutes of swimming or sweating •immediately after towel drying •at least every 2 hours •children under 6 months: Ask a doctor • 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 value of 15 or higher and other sun p...
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients
Meradimate 5.0%
Octinoxate 7.5%
Octisalate 5.0%
Oxybenzone 3.0%
Purpose
Sunscreen
Uses
•helps prevent sunburn.
•if 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.
Do not use on damaged or broken skin.
Stop use and ask a doctor if rash occurs.
When using this product keep out of eyes.
Rinse with water to remove.
Keep out of reach of children. If swallowed,
get medical help or contact a Poison
Control Center right away.
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
•children under 6 months: Ask a doctor
•
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 value of 15 or higher and other
sun protection measures including:
•limit time in the sun, especially from 10a.m.–2 p.m.
•wear long-sleeved shirts, pants, hats, and sun-glasses
Other Information
•protect this product from excessive heat and direct sun.
Inactive Ingredients
Aloe Vera Leaf, Benzyl Alcohol, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked), Cetyl Alcohol, Cetyl Dimethicone 45, Diazolidinyl Urea, Diethanolamine Cetyl Phospate, dl-Alpha Tocopheryl Acetate, Iodopropynyl Butylcarbamate, Stearic Acid, Talc, Trolamine, Water.
Questions or Comments
1-800-922-2883
RECENT MAJOR CHANGES SECTION
Uses 12/2020
Directions 12/2020
Package Label
NDC# 61619-864-08
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61619-864-02 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1a11-0266-e053-dadaa90a7c1a | 62668419-e513-496f-a8d2-afbfc411e81c |
| 61619-864-04 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1a11-0266-e053-dadaa90a7c1a | 62668419-e513-496f-a8d2-afbfc411e81c |
| 61619-864-08 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1a11-0266-e053-dadaa90a7c1a | 62668419-e513-496f-a8d2-afbfc411e81c |
| 61619-864-10 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1a11-0266-e053-dadaa90a7c1a | 62668419-e513-496f-a8d2-afbfc411e81c |
| 61619-864-32 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1a11-0266-e053-dadaa90a7c1a | 62668419-e513-496f-a8d2-afbfc411e81c |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61619-864-02 | Pro-Tect Sports Sunscreen SPF 20 | 59.1 mL in 1 BOTTLE, PLASTIC | LOTION | 59.1 | 7 | |
| 61619-864-04 | Pro-Tect Sports Sunscreen SPF 20 | 118.3 mL in 1 BOTTLE, PLASTIC | LOTION | 118.3 | 7 | |
| 61619-864-06 | Pro-Tect Sports Sunscreen SPF 20 | 29.6 mL in 1 BOTTLE, PLASTIC | LOTION | 29.6 | 7 | |
| 61619-864-08 | Pro-Tect Sports Sunscreen SPF 20 | 236.6 mL in 1 BOTTLE, PLASTIC | LOTION | 236.6 | 7 | |
| 61619-864-10 | Pro-Tect Sports Sunscreen SPF 20 | 1 in 1 BOX | LOTION | 1 | 7 | |
| 61619-864-32 | Pro-Tect Sports Sunscreen SPF 20 | 946.4 mL in 1 BOTTLE, PLASTIC | LOTION | 946.4 | 7 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MERADIMATE | ACTIVE INGREDIENT | J9QGD60OUZ | 3 | |
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 3 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 3 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 3 | |
| MERADIMATE | ACTIVE MOIETY | J9QGD60OUZ | 3 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 3 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 3 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 3 | |
| .ALPHA.-TOCOPHEROL ACETATE, DL- | INACTIVE INGREDIENT | WR1WPI7EW8 | 3 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 3 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | 3 | |
| CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | INACTIVE INGREDIENT | 809Y72KV36 | 3 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 3 | |
| CETYL DIMETHICONE 45 | INACTIVE INGREDIENT | IK315POC44 | 3 | |
| DIAZOLIDINYL UREA | INACTIVE INGREDIENT | H5RIZ3MPW4 | 3 | |
| DIETHANOLAMINE CETYL PHOSPHATE | INACTIVE INGREDIENT | 4UG0316V9S | 3 | |
| IODOPROPYNYL BUTYLCARBAMATE | INACTIVE INGREDIENT | 603P14DHEB | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 3 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 3 |
Products#
Every source-derived product name is available through these pages.
- Pro-Tect Sports Sunscreen SPF 20
- Meradimate, Octinoxate, Octisalate, Oxybenzone
- OCTINOXATE
- MERADIMATE
- OXYBENZONE
- OCTISALATE
- ALOE VERA LEAF
- BENZYL ALCOHOL
- DIAZOLIDINYL UREA
- CETYL ALCOHOL
- CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
- CETYL DIMETHICONE 45
- DIETHANOLAMINE CETYL PHOSPHATE
- .ALPHA.-TOCOPHEROL ACETATE, DL-
- IODOPROPYNYL BUTYLCARBAMATE
- STEARIC ACID
- TALC
- TROLAMINE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61619-864 | 61619-864-04, 61619-864-02, 61619-864-06, 61619-864-10, 61619-864-08, 61619-864-32 |
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 |
|---|---|---|---|---|---|---|
| TROLAMINE | TROLAMINE | 9O3K93S3TK | SOLUTION / TOPICAL | NA | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS | 18 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, ORALLY DISINTEGRATING / ORAL | 9 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / TOPICAL | 190 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE / ORAL | 349 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / INTRASYNOVIAL | 18 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | GEL, METERED / TOPICAL | 20 mg | ||
| DIAZOLIDINYL UREA | DIAZOLIDINYL UREA | H5RIZ3MPW4 | OINTMENT / TOPICAL | 0.1 %w/w | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SOLUTION / INTRA-ARTICULAR | 23 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | AEROSOL, FOAM / VAGINAL | 2 %w/w | ||
| CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | 809Y72KV36 | CREAM / TOPICAL | 2 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / SUBCONJUNCTIVAL | 252 mg | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE, DELAYED RELEASE / ORAL | 525 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | POWDER / TOPICAL | 0.02 mg/mg | ||
| CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | 809Y72KV36 | LOTION / TOPICAL | 29 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / ORAL | 360 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, EMULSION / INTRAVENOUS | 45 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 59 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SOLUTION / INTRAVENOUS | 400 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, DELAYED RELEASE / ORAL | 80 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SUSPENSION / AURICULAR (OTIC) | 0.9 %w/v | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / SOFT TISSUE | 23 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, DELAYED RELEASE / ORAL | 420 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / RECTAL | 32.4 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / SOFT TISSUE | 40 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SPRAY / NASAL | 5 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | CREAM, AUGMENTED / TOPICAL | 20 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | LOTION / TOPICAL | 80 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, EMULSION / SUBCUTANEOUS | 225 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | AEROSOL, METERED / RECTAL | ADJ PH | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / INTRAVENOUS | 242 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | GEL / VAGINAL | 100 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / INTRA-ARTICULAR | 40 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, EXTENDED RELEASE / ORAL | 5119 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SOLUTION / SUBCUTANEOUS | 0.95 %w/v | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / RECTAL | 17 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, EXTENDED RELEASE / ORAL | 132 mg | ||
| TALC | TALC | 7SEV7J4R1U | POWDER / TOPICAL | 9235 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET / ORAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, CHEWABLE / ORAL | 202 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRA-ARTERIAL | 0.9 %w/v | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE, FOR SUSPENSION / ORAL | 296 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 20 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | TABLET, DELAYED RELEASE / ORAL | 2.31 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SOLUTION / INTRAMUSCULAR | 500 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | LIQUID / TOPICAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, EXTENDED RELEASE / ORAL | 300 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | SHAMPOO / TOPICAL | 3.7 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 357 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRA-ARTICULAR | 1 %w/v | ||
| CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | 809Y72KV36 | EMULSION / OPHTHALMIC | 0.05 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED PELLETS / ORAL | 14 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / TOPICAL | 82 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | CREAM / VAGINAL | 1 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 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 |
|---|---|---|---|---|---|---|
| d39a1b0a-6fc0-6539-e053-2995a90a06f3 | 62668419-e513-496f-a8d2-afbfc411e81c | 2021-12-21 | Warnings | d39a1b0a-6fc0-6539-e053-2995a90a06f3 62668419-e513-496f-a8d2-afbfc411e81c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.