NDC | 24854-300-50, 24854-400-50 |
Set ID | 1a784b0e-a517-4510-a547-1334febfc0aa |
Category | HUMAN OTC DRUG LABEL |
Packager | Keraplast Technologies LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
- Apply in the morning over intensive serum as a moisturizing sunscreen. Smooth over face and neck, massaging in upward, outward, circular motions.
- Apply at least 15 minutes before sun exposure.
- Reapply every 2 hours if skin is being exposed to the sun.
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Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early signs of 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 am to 2 pm
- Wear long sleeved shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
- Inactive ingredients
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton
- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton
-
INGREDIENTS AND APPEARANCE
KERAS DAY SHIELD BROAD SPECTRUM SPF 25
octinoxate, avobenzone, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24854-400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51) octinoxate 0.25 g in 50 mL avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX) avobenzone 0.15 g in 50 mL octocrylene (UNII: 5A68WGF6WM) (octocrylene - UNII:5A68WGF6WM) octocrylene 0.4 g in 50 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) cetostearyl alcohol (UNII: 2DMT128M1S) isopropyl palmitate (UNII: 8CRQ2TH63M) polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY) glycerin (UNII: PDC6A3C0OX) gluconolactone (UNII: WQ29KQ9POT) sodium benzoate (UNII: OJ245FE5EU) potassium sorbate (UNII: 1VPU26JZZ4) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24854-400-50 1 in 1 CARTON 1 50 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 11/30/2011 RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25
octinoxate, avobenzone, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24854-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51) octinoxate 0.25 g in 50 mL avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX) avobenzone 0.15 g in 50 mL octocrylene (UNII: 5A68WGF6WM) (octocrylene - UNII:5A68WGF6WM) octocrylene 0.4 g in 50 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) cetostearyl alcohol (UNII: 2DMT128M1S) isopropyl palmitate (UNII: 8CRQ2TH63M) polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY) glycerin (UNII: PDC6A3C0OX) gluconolactone (UNII: WQ29KQ9POT) sodium benzoate (UNII: OJ245FE5EU) potassium sorbate (UNII: 1VPU26JZZ4) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24854-300-50 1 in 1 CARTON 1 50 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 11/30/2011 Labeler - Keraplast Technologies LLC (009952821) Establishment Name Address ID/FEI Business Operations The Cosmetic Company 590563383 LABEL, MANUFACTURE, PACK