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NDC 50066-0703-01 Cicatricure Aqua Defense Day With SPF 20; 50; 44; 90 mg/g; mg/g; mg/g; mg/g Details
Cicatricure Aqua Defense Day With SPF 20; 50; 44; 90 mg/g; mg/g; mg/g; mg/g
Cicatricure Aqua Defense Day With SPF is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Genomma Lab USA. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE.
Product Information
| NDC | 50066-0703 |
|---|---|
| Product ID | 50066-703_1593b1d7-11ab-4a0a-baff-e24260f89bd3 |
| 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 | Cicatricure Aqua Defense Day With SPF |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Avobenzone, Homosalate, Octisalate, and Octocrylene |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 20; 50; 44; 90 |
| Active Ingredient Units | mg/g; mg/g; mg/g; mg/g |
| Substance Name | AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE |
| Labeler Name | Genomma Lab USA |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part352 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 50066-0703-01 (50066070301)
| NDC Package Code | 50066-703-01 |
|---|---|
| Billing NDC | 50066070301 |
| Package | 1 JAR in 1 CARTON (50066-703-01) / 50 g in 1 JAR |
| Marketing Start Date | 2019-10-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 409a8745-98f9-4e5a-b2d0-7b5d19bd1279 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
Warnings
Directions
For sunscreen use
- apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating.
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 factor of 15 or higher and other skin protection measures including:
- limit time in the sun, especially from 10am to 2pm
- wear long-sleeved shirts, pants, hats and sunglasses
- children under 6 months of age: ask a doctor
Other information
Inactive ingredients
Water, Caprylyl Methicone, Glycerin, PEG-12 Dimethicone/PPG-20 Crosspolymer, Brassica Campestris/Aleurites Fordi Oil Copolymer, Phenoxyethanol, Polyacrylate-13, Polyisobutene, Trehalose, Urea, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Imidazolidinyl Urea, Fragrance, Disodium EDTA, Ethylhexylglycerin, Pentylene Glycol, Polysorbate 20, Serine, Sodium Hydroxide, Pullulan, Algin, Sodium Hyaluronate
PRINCIPAL DISPLAY PANEL - 50 g Jar Carton
INGREDIENTS AND APPEARANCE
| CICATRICURE AQUA DEFENSE DAY WITH SPF
avobenzone, homosalate, octisalate, and octocrylene cream |
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| Labeler - Genomma Lab USA (832323534) |
Revised: 1/2022
Document Id: 1593b1d7-11ab-4a0a-baff-e24260f89bd3
Set id: 409a8745-98f9-4e5a-b2d0-7b5d19bd1279
Version: 2
Effective Time: 20220114