Bioelements
- Product NDC
- 49825-114
- 11-digit product format
- 498250114
- Labeler code
- 49825
- Product ID
- 49825-114_19d7afa4-cd7c-4876-91f7-cf916fa73748
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Bioelements Inc.
- Application
- part352
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2009-01-01
- Marketing end
- 0000-00-00
- Substance
- OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE
- Active strength
- 8 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49825-114-01 | BioelementsSun Diffusing Protector SPF 15 | 177 mL in 1 BOTTLE | CREAM | 177 | | 6 |
| 49825-114-02 | BioelementsSun Diffusing Protector SPF 15 | 1 in 1 BOX | CREAM | 1 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
| ALKYL (C12-15) BENZOATE | INACTIVE INGREDIENT | A9EJ3J61HQ | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
| CITRUS AURANTIUM FLOWER OIL | INACTIVE INGREDIENT | D4BGE91OXH | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
| CITRUS AURANTIUM FRUIT OIL | INACTIVE INGREDIENT | 59JDQ5VT0T | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
| IMIDUREA | INACTIVE INGREDIENT | M629807ATL | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
| LAVENDER OIL | INACTIVE INGREDIENT | ZBP1YXW0H8 | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
| SAGE OIL | INACTIVE INGREDIENT | U27K0H1H2O | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49825-114 | BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] | 6 | Legacy NDC, 2 package rows | 20120127_6550938a-7299-4e4b-aafe-4d5ce13e79a5.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 49825-114-01 | 49825011401 | 177 mL in 1 BOTTLE | 177 ml | Historical |
| 49825-114-02 | 49825011402 | 1 in 1 BOX | | Historical |