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NDC 68828-0171-02 Medium Skin Defense Concealer Broad Spectrum SPF 15 7; 3; 2 g/100mL; g/100mL; g/100mL Details
Medium Skin Defense Concealer Broad Spectrum SPF 15 7; 3; 2 g/100mL; g/100mL; g/100mL
Medium Skin Defense Concealer Broad Spectrum SPF 15 is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Jafra Cosmetics International Inc. The primary component is OCTINOXATE; OCTISALATE; OXYBENZONE.
Product Information
| NDC | 68828-0171 |
|---|---|
| Product ID | 68828-171_dec3c88a-9b66-a5c3-e053-2995a90aec4c |
| 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 | Medium Skin Defense Concealer Broad Spectrum SPF 15 |
| Proprietary Name Suffix | Jafra |
| Non-Proprietary Name | Octinoxate, Octisalate, Oxybenzone |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 7; 3; 2 |
| Active Ingredient Units | g/100mL; g/100mL; g/100mL |
| Substance Name | OCTINOXATE; OCTISALATE; OXYBENZONE |
| Labeler Name | Jafra Cosmetics International Inc |
| 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 68828-0171-02 (68828017102)
| NDC Package Code | 68828-171-02 |
|---|---|
| Billing NDC | 68828017102 |
| Package | 1 TUBE in 1 CARTON (68828-171-02) / 15 mL in 1 TUBE (68828-171-01) |
| Marketing Start Date | 2013-05-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 3d261d0d-a122-4e5e-86ac-89a19d3e8999 Details
SPL UNCLASSIFIED SECTION
Active Ingredients Purpose
Octinoxate 7% Sunscreen
Octisalate 3% Sunscreen
Oxybenzone 2% Sunscreen
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
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Stop use and ask a doctor if rash occurs
Warnings
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Directions
Apply liberally 15 minutes before sun exposure
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
Children under 6 months: Ask a doctor
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 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
Inactive ingredients: Water/Aqua, Butylene Glycol, Glyceryl Stearate, Stearic Acid, Isopropyl Isostearate, Di-PPG-3 Myristyl Ether Adipate, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Cetyl Alcohol, Triethanolamine, Lecithin, Silica, Dimethicone, Polysorbate 20, Hydrolyzed Lupinus Albus (Lupine) Protein, Medicago Sativa (Alfalfa) Seed Extract, DMDM Hydantoin, Xanthan Gum, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Magnesium Aluminum Silicate, Tocopheryl Acetate, Tagetus Erecta (African Marigold) Extract, Ipomoea Batatas Tuber Extract, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Trisodium EDTA [May Contain +/- : Titanium Dioxide/CI 77891, Iron Oxides/CI 77491/CI 77492/CI 77499]
INGREDIENTS AND APPEARANCE
| LIGHT SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15
JAFRA
octinoxate, octisalate, oxybenzone cream |
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| MEDIUM SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15
JAFRA
octinoxate, octisalate, oxybenzone cream |
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| DARK SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15
JAFRA
octinoxate, octisalate, oxybenzone cream |
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| Labeler - Jafra Cosmetics International Inc (041676479) |
| Registrant - Jafra Cosmetics International Inc (041676479) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Distribuidora Comercial Jafra, S.A. de C.V. | 951612777 | manufacture(68828-170, 68828-171, 68828-172) | |