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NDC 58411-0101-10 SHISEIDO IBUKI PROTECTIVE MOISTURIZER 1903; 5633; 1522; 761 mg/76.12g; mg/76.12g; mg/76.12g; mg/76.12g Details
SHISEIDO IBUKI PROTECTIVE MOISTURIZER 1903; 5633; 1522; 761 mg/76.12g; mg/76.12g; mg/76.12g; mg/76.12g
SHISEIDO IBUKI PROTECTIVE MOISTURIZER is a TOPICAL EMULSION in the HUMAN OTC DRUG category. It is labeled and distributed by SHISEIDO AMERICAS CORPORATION. The primary component is AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE.
Product Information
| NDC | 58411-0101 |
|---|---|
| Product ID | 58411-101_7cf0cb08-78a7-306c-e053-2a91aa0ae822 |
| 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 | SHISEIDO IBUKI PROTECTIVE MOISTURIZER |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | EMULSION |
| Route | TOPICAL |
| Active Ingredient Strength | 1903; 5633; 1522; 761 |
| Active Ingredient Units | mg/76.12g; mg/76.12g; mg/76.12g; mg/76.12g |
| Substance Name | AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE |
| Labeler Name | SHISEIDO AMERICAS CORPORATION |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part352 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 58411-0101-10 (58411010110)
| NDC Package Code | 58411-101-10 |
|---|---|
| Billing NDC | 58411010110 |
| Package | 1 BOTTLE in 1 CARTON (58411-101-10) / 76.12 g in 1 BOTTLE |
| Marketing Start Date | 2013-08-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 17d47248-f03f-4dd9-b242-af7fcbd95761 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 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 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-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
Inactive Ingredients
WATER, SD ALCOHOL 40-B, GLYCERIN, DIPROPYLENE GLYCOL, DIMETHICONE, ETHYLHEXYL PALMITATE, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, SILICA, TREHALOSE, BETAINE, GLYCYL GLYCINE, LAURYL BETAINE, PAEONIA ALBIFLORA ROOT EXTRACT, HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF EXTRACT, LAMIUM ALBUM FLOWER EXTRACT, CITRUS JUNOS SEED EXTRACT, ZINGIBER AROMATICUS EXTRACT, PEG-20 GLYCERYL ISOSTEARATE, TRIISOSTEARIN, TRIETHANOLAMINE, ISOSTEARIC ACID, ALCOHOL, BUTYLENE GLYCOL, CARBOMER, BATYL ALCOHOL, BEHENYL ALCOHOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, TRISODIUM EDTA, SODIUM METABISULFITE, BHT, PHENOXYETHANOL, SODIUM BENZOATE, BENZOIC ACID, FRAGRANCE, TITANIUM DIOXIDE, MICA,
PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton
INGREDIENTS AND APPEARANCE
| SHISEIDO IBUKI PROTECTIVE MOISTURIZER
avobenzone, octinoxate, octocrylene, and oxybenzone emulsion |
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| Labeler - SHISEIDO AMERICAS CORPORATION (193691821) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| SHISEIDO AMERICA INC. | 782677132 | manufacture(58411-101) , analysis(58411-101) | |
Revised: 12/2018
Document Id: 7cf0cb08-78a7-306c-e053-2a91aa0ae822
Set id: 17d47248-f03f-4dd9-b242-af7fcbd95761
Version: 2
Effective Time: 20181213