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NDC 62032-0300-09 Obagi 360 HydraFactor Moisturizing Broad Spectrum SPF 30 10; 75; 50; 50 mg/g; mg/g; mg/g; mg/g Details
Obagi 360 HydraFactor Moisturizing Broad Spectrum SPF 30 10; 75; 50; 50 mg/g; mg/g; mg/g; mg/g
Obagi 360 HydraFactor Moisturizing Broad Spectrum SPF 30 is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by OBAGI COSMECEUTICAL LLC. The primary component is AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE.
Product Information
| NDC | 62032-0300 |
|---|---|
| Product ID | 62032-300_a76e015e-f360-42bc-bfe9-4b87de597cf5 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Obagi 360 HydraFactor Moisturizing Broad Spectrum SPF 30 |
| Proprietary Name Suffix | SUNSCREEN |
| Non-Proprietary Name | AVOBENZONE, OCTINOXATE, OCTISALATE, and OXYBENZONE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 10; 75; 50; 50 |
| Active Ingredient Units | mg/g; mg/g; mg/g; mg/g |
| Substance Name | AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE |
| Labeler Name | OBAGI COSMECEUTICAL LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part352 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 62032-0300-09 (62032030009)
| NDC Package Code | 62032-300-09 |
|---|---|
| Billing NDC | 62032030009 |
| Package | 1 TUBE in 1 CARTON (62032-300-09) / 75 g in 1 TUBE |
| Marketing Start Date | 2020-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 84f0f1dd-13f2-49f5-89b3-fab175ac2564 Details
SPL UNCLASSIFIED SECTION
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
Directions
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
-
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 10 a.m.–2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
Other information
Inactive ingredients
water (aqua), C12-15 alkyl benzoate, butyloctyl salicylate, glycerin, sodium hyaluronate, eperua falcata bark extract, dextrin, polysorbate 20, hydrolyzed caesalpinia spinosa gum, caesalpinia spinosa gum, sodium hydroxide, carbomer, acrylates/C10-30 alkyl acrylate crosspolymer, caprylyl glycol, disodium EDTA, hexylene glycol, pichia/resveratrol ferment extract, sorbitan oleate, tocopheryl acetate, ubiquinone, phenoxyethanol, ethylhexylglycerin
PRINCIPAL DISPLAY PANEL - 75 g Tube Carton
INGREDIENTS AND APPEARANCE
| OBAGI 360 HYDRAFACTOR MOISTURIZING BROAD SPECTRUM SPF 30
SUNSCREEN
avobenzone, octinoxate, octisalate, and oxybenzone cream |
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| Labeler - OBAGI COSMECEUTICAL LLC (790553353) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| G.S Cosmeceutical | 017014734 | MANUFACTURE(62032-300) , LABEL(62032-300) , PACK(62032-300) | |
Revised: 9/2019
Document Id: a76e015e-f360-42bc-bfe9-4b87de597cf5
Set id: 84f0f1dd-13f2-49f5-89b3-fab175ac2564
Version: 3
Effective Time: 20190903