![FAIR AND SQUARE KIDS SUNSCREEN SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [PRIME ENTERPRISES, INC.]](https://medic.hrt.org//dailymed/images/75835d93-1171-4f63-bf15-c0c2e20bed83/58441-0151-4.jpg)
| NDC | 58443-0151-4 |
| Set ID | 75835d93-1171-4f63-bf15-c0c2e20bed83 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Prime Enterprises, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- Active ingredients
- Purpose
- Uses
- Warnings
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Directions: apply liberally 15 minutes before sun exposure
reapply:
- after 80 minutes of swimming or sweating
- Immediately after towel drying
- at least every 2 hours
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher & 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
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Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Fragrance (Parfum), Hydroxypropyl Methylcellulose, Methylisothiazolinone, Methylparaben, Polyethylene, Polyhydroxystearic Acid, Polysorbate 20, Propylene Glycol, Propylparaben, Sorbitan Oleate, Styrene/ Acrylates Copolymer, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua)
- Other information
- PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
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INGREDIENTS AND APPEARANCE
FAIR AND SQUARE KIDS SUNSCREEN SPF 50
homosalate, octinoxate, octisalate, and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0151 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 149.7 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 74.85 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 49.9 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 23.952 mg in 1 mL Inactive Ingredients Ingredient Name Strength C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) EDETATE DISODIUM (UNII: 7FLD91C86K) HYPROMELLOSES (UNII: 3NXW29V3WO) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLPARABEN (UNII: A2I8C7HI9T) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) COCOA BUTTER (UNII: 512OYT1CRR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0151-4 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/19/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/19/2014 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprises, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 label(58443-0151) , pack(58443-0151) , manufacture(58443-0151) , analysis(58443-0151)
