Pro-Tect Sports Sunscreen SPF 20
- Product NDC
- 61619-864
- Requested package NDC
- 61619-864-06
- 11-digit product format
- 616190864
- Labeler code
- 61619
- Product ID
- 61619-864_d39a1b0a-6fc0-6539-e053-2995a90a06f3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Meradimate, Octinoxate, Octisalate, Oxybenzone
- Dosage form
- LOTION
- Route
- CUTANEOUS
- Labeler
- A-Cute Derm, Incorporated
- Application
- part352
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2016-02-05
- Marketing end
- 0000-00-00
- Substance
- OCTINOXATE; MERADIMATE; OXYBENZONE; OCTISALATE
- Active strength
- 75 mg/mL; mg/mL; mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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 Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MERADIMATE | ACTIVE INGREDIENT | J9QGD60OUZ | PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] | 3 | |
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] | 3 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] | 3 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] | 3 | |
| MERADIMATE | ACTIVE MOIETY | J9QGD60OUZ | PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] | 3 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] | 3 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] | 3 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] | 3 | |
| .ALPHA.-TOCOPHEROL ACETATE, DL- | INACTIVE INGREDIENT | WR1WPI7EW8 | PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] | 3 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] | 3 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] | 3 | |
| CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | INACTIVE INGREDIENT | 809Y72KV36 | PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] | 3 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] | 3 | |
| CETYL DIMETHICONE 45 | INACTIVE INGREDIENT | IK315POC44 | PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] | 3 | |
| DIAZOLIDINYL UREA | INACTIVE INGREDIENT | H5RIZ3MPW4 | PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] | 3 | |
| DIETHANOLAMINE CETYL PHOSPHATE | INACTIVE INGREDIENT | 4UG0316V9S | PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] | 3 | |
| IODOPROPYNYL BUTYLCARBAMATE | INACTIVE INGREDIENT | 603P14DHEB | PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] | 3 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | PRO-TECT SPF 20 BROAD-SPECTRUM UVA/UVB SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61619-864 | PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [A-CUTE DERM, INCORPORATED] | 7 | Legacy NDC, 6 package rows | 20211222_62668419-e513-496f-a8d2-afbfc411e81c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61619-864-06 | 61619086406 | 29.6 mL in 1 BOTTLE, PLASTIC (61619-864-06) | 29.6 ml | 2016-02-05 | 0000-00-00 | No | No | Current |