Sunscreen
- Product NDC
- 61010-6103
- 11-digit product format
- 610106103
- Labeler code
- 61010
- Product ID
- 61010-6103_10dfe53b-4cdd-c203-e063-6294a90af360
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Homosalate, Octinoxate, Octisalate, Oxybenzone
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Safetec of America, Inc.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2007-03-13
- Substance
- HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE
- Active strength
- 6; 7.5; 5; 5 mg/g; mg/g; mg/g; mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sunscreen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HOMOSALATE | 6 mg/g |
| OCTINOXATE | 7.5 mg/g |
| OCTISALATE | 5 mg/g |
| OXYBENZONE | 5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V06SV4M95S, 4Y5P7MUD51, 4X49Y0596W, 95OOS7VE0Y |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61010-6103-0 | Sunscreen | 3.5 g in 1 PACKET | LOTION | 3.5 | | 6 |
| 61010-6103-1 | Sunscreen | 25 in 1 BOX | LOTION | 25 | | 6 |
| 61010-6103-2 | Sunscreen | 2 g in 1 PACKET | LOTION | 2 | | 6 |
| 61010-6103-3 | Sunscreen | 25 in 1 BOX | LOTION | 25 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Homosalate | ACTIVE INGREDIENT | V06SV4M95S | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| Octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| Octisalate | ACTIVE INGREDIENT | 4X49Y0596W | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| Oxybenzone | ACTIVE INGREDIENT | 95OOS7VE0Y | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| Homosalate | ACTIVE MOIETY | V06SV4M95S | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| Octisalate | ACTIVE MOIETY | 4X49Y0596W | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| Oxybenzone | ACTIVE MOIETY | 95OOS7VE0Y | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| cetyl alcohol | INACTIVE INGREDIENT | 936JST6JCN | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| diazolidinyl urea | INACTIVE INGREDIENT | H5RIZ3MPW4 | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| dimethicone | INACTIVE INGREDIENT | 92RU3N3Y1O | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| edetate sodium | INACTIVE INGREDIENT | MP1J8420LU | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| petrolatum | INACTIVE INGREDIENT | 4T6H12BN9U | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| polyethylene glycol 400 | INACTIVE INGREDIENT | B697894SGQ | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| polyoxyl 40 stearate | INACTIVE INGREDIENT | 13A4J4NH9I | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| povidone K30 | INACTIVE INGREDIENT | U725QWY32X | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| sorbitan monostearate | INACTIVE INGREDIENT | NVZ4I0H58X | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
| xanthan gum | INACTIVE INGREDIENT | TTV12P4NEE | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61010-6103 | SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240214_754186c8-3c88-40a0-a4e3-35e3ea9d1b4c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61010-6103-0 | 61010610300 | 3.5 g in 1 PACKET | 3.5 g | | | | | Historical |
| 61010-6103-1 | 61010610301 | 25 PACKET in 1 BOX (61010-6103-1) / 3.5 g in 1 PACKET (61010-6103-0) | 25 packet | 2007-03-13 | 0000-00-00 | No | No | Current |
| 61010-6103-2 | 61010610302 | 2 g in 1 PACKET | 2 g | | | | | Historical |
| 61010-6103-3 | 61010610303 | 25 PACKET in 1 BOX (61010-6103-3) / 2 g in 1 PACKET (61010-6103-2) | 25 packet | 2018-07-01 | 0000-00-00 | No | No | Current |